EMA and FDA accept Roche's MS therapy for review

by Amy Schofield 29. June 2016 15:36

The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) have accepted Roche's OCREVUS® (ocrelizumab) for review.

The EMA has validated Roche's Marketing Authorisation Application (MAA) of OCREVUS® (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in the European Union (EU). Validation confirms that the submission is complete and signifies the MAA is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The U.S. Food and Drug Administration (FDA) has also accepted for review Roche’s Biologics License Application (BLA) for OCREVUS for the treatment of RMS and PPMS, and has granted the application Priority Review Designation with a targeted action date of 28 December 2016.

If approved by the EMA and FDA for both indications, OCREVUS would be the first and only treatment for both forms of multiple sclerosis (MS), which affect approximately 95% of people at diagnosis.

OCREVUS is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS.

Dr Sandra Horning, chief medical officer and head of Global Product Development, said: “We will continue to work closely with the EMA and FDA to bring this investigational medicine to people with MS as quickly as possible.”

The OCREVUS marketing applications are based on positive results from three Phase III studies, which met primary and key secondary endpoints.

AOP Orphan Pharmaceuticals announces progress of pivotal phase III trial

by Admin 5. March 2015 17:18

AOP Orphan has announced completion of recruitment of its pivotal phase III trial PROUD-PV (proud-pv.com) to support global licensure of Ropeginterferon alfa 2b.

Ropeginterferon alfa 2b is a novel, long-acting, mono-pegylated Interferon, administered once every 14 days, after achieving therapy response only monthly.

Based on previous phase I/II trials, Ropeginterferon alfa 2b is expected to be safe and effective in the majority of PV patients.

Haematological and molecular responses occurred in most patients, while several patients achieved undetectable mutated JAK2 levels and a complete normalisation of their chromosomal make-up.

Ultimately, this is expected to result in improved tolerability, convenience and compliance and, as a consequence, better long-term treatment outcomes.

Design and endpoints of this trial have been discussed and agreed with both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), to support global licensure of Ropeginterferon alfa 2b, which also has Orphan Drug status in both Europe and the USA.

AOP Orphan has exclusively licensed Ropeginterferon alfa 2b for development and commercialisation in the field of Myeloproliferative Neoplasms (MPNs) from Pharmaessentia Corp. a biotech company based in Taiwan for European, CIS, and Middle Eastern markets. Pharmaessentia retains the rights for development and commercialization of P1101 in other major markets, such as North America, Asia, and South America.

Since its commencement in October 2013 over 260 PV patients have been recruited in 50 centres across Europe. Enrolment of patients was successfully completed in February 2015.

Treatment with Ropeginterferon alfa 2b is expected to be safe and effective in the majority of patients and to be superior to hydroxyurea.

Professors Jean-Jacques Kiladjian from Paris and Heinz Gisslinger from Vienna said: “We already know from several smaller studies that interferons work effectively against myeloproliferative diseases.”

Dr. Rudolf Widmann, CEO of AOP Orphan, said: “The unparalleled quick uptake and progress of PROUD-PV, completing enrolment of over 260 patients in around 15 months, proves the eagerness of both patients and physicians for this new treatment paradigm.”

Janssen receives positive CHMP opinion for VELCADE® (bortezomib)

by Admin 22. December 2014 15:47

Janssen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of VELCADE® (bortezomib) for use in Mantle Cell Lymphoma.

The drug has been recommended in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for haematopoietic stem cell transplantation.

The positive opinion of the CHMP was based on data from the Phase 3 study, LYM-3002. In the European Union (EU), VELCADE is currently indicated for the treatment of multiple myeloma (MM), another rare blood cancer, either as monotherapy or in combination with of other treatment regimens.

MCL is a rare and aggressive type of blood cancer that can be challenging to treat and is associated with a poor prognosis.

Thomas Stark, Vice President, Medical Affairs, Janssen Europe, Middle East and Africa (EMEA), said: "At Janssen, we are committed to continuously developing therapeutic solutions to treat relevant, haematologic diseases like MCL.

"This positive opinion brings us one step closer to offering additional treatment options with VELCADE for patients and physicians, and we are delighted with this recommendation."

The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to grant a label extension for medicines in the European Economic Area. A final decision on VELCADE's use in MCL by the European Commission is anticipated early next year.

Bayer HealthCare develops new treatment for haemophilia A

by Admin 5. December 2014 16:17

Bayer HealthCare has developed a promising new recombinant factor VIII product for the treatment of haemophilia A in adults and children but is waiting European approval.

The application for marketing authorisation has been submitted to the European Medicines Agency for BAY 81-8973 based on positive results from three phase III clinical trials, involving a total of 2014 subjects.

Clinical Studies into the drug show high-levels of efficacy when used for prophylaxis twice or three times per week with standard dosages. Its capacity for flexible dosing gives greater choice in finding the right option for individual patients.

Bayer also plans to file for approval of BAY 81-8973 in other countries in the coming months.

Dr Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development, said: "The submission of BAY 81-8973 is an important step forward in our efforts to improve treatment options for people with haemophilia."

The company started work on expanding its manufacturing capabilities for haemophilia A products in Germany earlier this year in order to support the production of this therapy, as well as the long-acting agent BAY 94-9027.

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Novartis' new heart failure drug to get accelerated EU review

by Admin 1. December 2014 09:51

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment status to Novartis’ investigational heart failure drug, LCZ696.

The new heart failure drug, intended for patients with heart failure with reduced ejection fraction, is to benefit from an accelerated European review process which will allow the CHMP to grant an opinion after 150 days instead of the normal 210.

Accelerated review status is seldom granted and has never before been awarded to a cardiovascular therapy. A decision on EU approval is now expected to arrive during 2015. 

The regulatory submission will be based on results from the largest ever landmark study conducted in heart failure, PARADIGM-HF. The results showed that LCZ696 can significantly reduce the risk of cardiovascular death or heart failure hospitalisation compared to an established alternative.

David Epstein, division head of Novartis Pharmaceuticals, said: "Novartis is committed to extending and improving more lives sooner with LCZ696, and this decision by the CHMP we hope will greatly support our effort to do so in Europe."


Nintedanib gets positive EU CHMP opinion for IPF treatment

by Admin 26. November 2014 09:36

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Boehringer Ingelheim’s nintedanib* for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

Results from the Phase III INPULSIS® trials, published in the New England Journal of Medicine in May 2014, showed that nintedanib (suggested brand name OFEV®) significantly slowed disease progression in patients with IPF.  The opinion follows the recent Food and Drug Administration (FDA) approval of nintedanib for the treatment of IPF.

IPF is a progressive and severely debilitating lung disease with a high mortality rate. It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing. 

The CHMP's positive opinion is based on pivotal data from the replicate Phase III INPULSIS® trials involving 1,066 patients from 24 countries.

INPULSIS® study investigator Professor Luca Richeldi, Professor of Respiratory Medicine, Chair of Interstitial Lung Disease at the University of Southampton, said: "For the first time we have a drug that has consistently met the primary endpoint in two large Phase III trials, confirming the results of the Phase II trial."

Dr Charles de Wet, UK Medical Director at Boehringer Ingelheim, said: "Boehringer Ingelheim welcomes the decision by the CHMP to grant nintedanib a positive opinion. IPF is a highly debilitating disease for patients and there are currently only limited treatment options that are able to slow disease progression. We hope that we are able to make nintedanib available to these patients in the EU soon."

* Nintedanib is currently being assessed by the European Medicines Agency (EMA) and other regulatory organisations worldwide.


EU recommendation for AbbVie’s next-gen hep C treatment

by Admin 24. November 2014 10:47

The European Medicines Agency (EMA) has recommended approval for AbbVie’s combination treatment for hepatitis C virus (HCV).

AbbVie's three-agent combination uses antivirals to halt viral replication, resulting in cures for over 90% of hep C patients. If AbbVie does secure EMA approval, AbbVie will be on track for launching the product in Europe in early 2015.

In pivotal trials on thousands of patients, AbbVie's multi-pill combination eradicated the hep C virus in patients with all genotypes without the need for painful interferon injections.

The EMA has recommended a marketing authorisation for Exviera (dasabuvir) and Viekirax (ombitasvir + paritaprevir + ritonavir) for the treatment of chronic hepatitis C virus (HCV) infection in adults in combination with other medicinal products for the treatment of chronic hepatitis C.

Exviera and Viekirax belong to a new generation of medicines for chronic HCV infection. Both block the action of proteins which are essential for HCV replication. Exviera targets the protein NS5B while Viekirax targets the proteins NS5A and NS3/4A.

HCV infection is a major European public health challenge which affects between 0.4% and 3.5% of the population in different EU member States. It is the most common single cause of liver transplantation in the EU.


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Roche's Esbriet gets CHMP approval for label update

by Admin 29. October 2014 10:46

Roche's idiopathic pulmonary fibrosis therapy, Esbriet, has received CHMP recommendation for a prescribing information label update.

Roche has announced that the European Medicines Agency committee has recommended the approval of a planned label update on prescribing information for its drug Esbriet which will help to strengthen its safety and efficacy profile. The update has received a positive opinion from Europe's Committee for Medicinal Products for Human Use (CHMP).

New data that will be included on the label will reflect the findings of a pooled analysis of the clinical trial programmes ASCEND and CAPACITY, which showed the drug can deliver a 48% reduction in mortality risk at one year.

It was also found that the risk of treatment-emergent disease-related mortality among Esbriet patients was reduced by 68% compared to placebo within the same time period.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "The inclusion of the Ascend data in the European prescribing label for Esbriet will provide important additional information for physicians and patients."

Novartis gets CHMP nod for acromegaly drug

by Admin 1. October 2014 10:52

Novartis has announced that Signifor’s long-acting release (LAR) formulation has been recommended for European approval for treating acromegaly, a rare hormonal disorder.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has approved the drug for use in the treatment of adult patients with acromegaly for whom surgery is not an option or has not cured their condition. It has also been endorsed for those who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA).

Data from two phase III trials has demonstrated the superior efficacy of the therapy in providing biochemical control compared to treatments with SSAs.

Acromegaly is an endocrine disorder caused by elevated growth hormone and insulin-like growth factor-1 levels. The condition can result in the enlargement of hands, feet, facial features and internal organs and leads to serious health consequences.

Commenting on the CHMP approval, Dr Alessandro Riva, global head of Novartis oncology development and medical affairs, said: "This positive CHMP opinion for Signifor LAR formulation represents a significant step towards our goal of being able to offer adult patients with inadequately controlled acromegaly in the EU a much-needed alternative treatment option."


EMA thumbs-up for Boehringer Ingelheim lung cancer drug

by Admin 29. September 2014 13:59

Boehringer Ingelheim has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for their non-small cell lung cancer drug nintedanib in combination with docetaxel.

The opinion has been issued on the combination for the treatment of patients with advanced non-small cell lung cancer (NSCLC) of adenocarcinoma histology after first line chemotherapy.

The CHMP’s positive opinion is now referred to the European Commission (EC), which grants marketing authorisation for medicines in the European Union. If approved, nintedanib will be the first triple angiokinase inhibitor licensed for the treatment of second-line adenocarcinoma of the lung. Nintedanib is an investigational agent and is not currently licensed in the UK.

Dr Yvonne Summers, Consultant Medical Oncologist from The Christie NHS Foundation Trust, said: “Given that lung cancer is the second most common cancer in the UK, this recommendation for European approval is promising news for patients and clinicians managing this disease.”

The CHMP positive opinion is based on the international, randomised, double-blind, placebo-controlled, Phase III LUME-Lung 1 trial which compared nintedanib plus docetaxel to placebo plus docetaxel in patients with locally advanced/metastatic or recurrent NSCLC after failure of first-line therapy. 

Around 43,000 new lung cancer cases are diagnosed each year, making it the second most common cancer in the UK. NSCLC is the most common type of lung cancer, accounting for around 72% of all cases in England and Wales with adenocarcinoma being the most common histology.

Lung cancer is the leading cause of cancer mortality, accounting for more than a fifth of all cancer deaths in the UK.

Zinta Krumins, Managing Director of Boehringer Ingelheim Ltd in the UK said, “The CHMP’s positive opinion for nintedanib is good news for patients, their families and their doctors. Lung disease, from asthma and COPD to lung cancer, is a specific interest for Boehringer Ingelheim. This is our second lung cancer medicine and an important milestone for our future”.



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