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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Drugs | General | News

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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Drugs | News

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”.


Daklinza®▼ (daclatasvir) launches in the UK

by Admin 8. September 2014 12:30

Bristol-Myers Squibb has announced the launch of Daklinza®▼ (daclatasvir) in the UK, offering a new treatment combination for chronic hepatitis C shown to provide cure in a high number of patients.

Daclatasvir is an oral, once-a-day pill, used in combination with other medicinal products, to treat adult patients with chronic hepatitis C. In combination with other agents it works across multiple hepatitis C genotypes. 

In 2014, the New England Journal of Medicine (NEJM) reported that daclatasvir (the first NS5A inhibitor to be licensed in Europe), used in combination with sofosbuvir, offered clinical cure rates of 98% and 89% in patients with hepatitis C genotype 1 and 3 respectively. Daclatasvir has also shown, in a separate study, to provide clinical cure rates in hepatitis C genotype 4 of up to 100% when combined with peginterferon alfa and ribavirin.

Daclatasvir offers the option of a curative oral regimen that does not require interferon2, commonly associated with sustained flu-like side effects, for around 90% of cases in the UK. 

Charles Gore, Chief Executive of The Hepatitis C Trust, said: “We are delighted by today’s announcement. Each new treatment for hepatitis C takes us closer to making the elimination of hepatitis C a realistic possibility, by improving both cure rates and tolerability.”

In January 2014, daclatasvir was brought forward for priority review by the European Medicines Agency (EMA), recognising the unmet need that exists in the hepatitis C patient population.

“We are committed to improving the quality of life of patients living with hepatitis C and paving the way to cure this chronic and devastating condition,” said Johanna Mercier, General Manager, Bristol-Myers Squibb, UK and Ireland. 

Eisai files lenvatinib in Europe for hard to treat thyroid cancer

by Admin 18. August 2014 14:44

Eisai has announced that it has filed an application to the European Medicines Agency (EMA) for the use of lenvatinib in the treatment of patients with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC). 

The EMA’s Committee for Medicinal Products for Human Use (CHMP) accepted Eisai’s request for accelerated assessment of lenvatinib in recognition that RR-DTC is a challenging disease with an urgent need for effective treatment options. 

Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor (TKI) with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor receptors (VEGFR), in addition to other proangiogenic and oncogenic pathway-related TKIs including fibroblast growth factor receptors (FGFR), the platelet-derived growth factor (PDGF) receptor PDGFRα, KIT and RET that are involved in tumour proliferation. 

The EU Marketing Authorisation Application (MAA) is based on the results of the Phase III SELECT (study of (E7080) lenvatinib in differentiated cancer of the thyroid) trial of lenvatinib (E7080). The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.

Results showed that, compared to placebo, lenvatinib produced a highly statistically significant improvement in progression free survival (PFS) in patients with RR-DTC. The median PFS with lenvatinib and placebo were 18.3 months and 3.6 months, respectively.

The SELECT study was a multicentre, randomised, double-blind, placebo-controlled Phase III study to compare the PFS of patients with RR-DTC and radiographic evidence of disease progression within the prior 13 months, treated with once-daily, orallenvatinib (24mg) versus placebo. 

Lenvatinib, discovered and developed by Eisai, was filed in Japan in June 2014 and in August 2014 in the US. Lenvatinib was granted orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer by the European Commission in April 2013. 


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RemsimaTM set for UK launch by Napp

by Admin 14. August 2014 09:37

Napp Pharmaceuticals Ltd, an independent associate of Mundipharma International Corporation Ltd, will have exclusive rights to distribute RemsimaTM in the UK after expiry of the reference product’s exclusivity in February 2015.

RemsimaTM has been recommended for authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The product is a biosimilar medicinal product containing the monoclonal antibody, infliximab. 

RemsimaTM will not be available in the UK until after the 24 February 2015, when the patent/Supplementary Protection Certificate protecting the infliximab antibody expires.

The therapeutic indications for RemsimaTM are the same as those of the originator infliximab product. These are rheumatoid arthritis, psoriatic arthritis, psoriasis, ankylosing spondylitis, adult and paediatric Crohn’s disease and adult and paediatric ulcerative colitis.

The pharmaceutical form (powder for concentrate for solution for infusion), dosing regimen, and strength (100 mg infliximab per vial) are also unchanged from the originator product.

Dietmar Leitner, Managing Director, Napp Pharmaceuticals, said, “Bringing Celltrion’s RemsimaTM to the UK market is the start of a new chapter in Napp’s story, which represents a great opportunity for us to continue working in partnership with the NHS to deliver overall efficiencies whilst maintaining high standards of patient care.”



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