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.”


Pfizer applies for EU approval of new indication for vaccine

by Admin 11. August 2014 11:04

Pfizer has applied to the European Medicines Agency for approval of its vaccine product Prevenar 13 in a new indication.

Pfizer is keen to expand the label of the pneumococcal polysaccharide conjugate vaccine to include the prevention of pneumonia in adults caused by the 13 pneumococcal serotypes present in the vaccine.

Prevenar 13 was first approved in Europe in December 2009 for the prevention of invasive pneumococcal disease.

Data from the landmark Community-Acquired Pneumonia Immunisation Trial in Adults showed that the vaccine can deliver statistically significant reductions in vaccine-type pneumococcal community-acquired pneumonia (CAP) - including non-invasive/non-bacteremic CAP - and invasive pneumococcal disease in adults aged 65 and older.

Dr Emilio Emini, senior vice-president for vaccine research and development at Pfizer, said: "The results of the Community-Acquired Pneumonia Trial in Adults study underscore the potential benefits of Prevenar 13 in preventing disease in this age group."


CHMP endorses Janssen blood cancer drug approval

by Admin 31. July 2014 11:08

Janssen has announced that its cancer therapy Imbruvica has been recommended for European approval against two forms of blood cancer.

The European Medicines Agency's (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of the drug as a treatment for adult patients with relapsed or refractory mantle cell lymphoma, or chronic lymphocytic leukaemia.

Developed by Janssen and Pharmacyclics Switzerland, the drug works by blocking BTK, a protein that helps certain cancer cells live and grow.

The therapy is intended for patients who have received at least one prior therapy, or in first-line use in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. The treatment has shown its safety and efficacy in a number of clinical trials.

Jane Griffiths, group chairman for Janssen in Europe, the Middle East and Africa, said: "We've been closely collaborating with the CHMP on the Imbruvica submission and are delighted to receive the positive opinion earlier than expected."

The product has also now been approved by the US Food and Drug Administration for the treatment of chronic lymphocytic leukaemia.

GSK with the world’s first malaria vaccine

by Admin 29. July 2014 09:04

GSK has filed for approval for what could potentially be the world’s first malaria vaccine.

GlaxoSmithKline (GSK) is waiting on approval for what could be the world’s first malaria vaccine following trials in which children given the vaccine had a 46% lower incidence of malaria than those without.

The vaccine, RTS,S, works to protect the body against the most dangerous of the four species of the malaria parasites, Plasmodium falciparum. This parasite is most commonly found in sub-Saharan Africa, where malaria kills more than 600,000 people each year, the majority of the victims being under five years old.

GSK has been developing the vaccine for three decades and has now submitted a marketing application to the European Medicines Agency (EMA) and the World Health Organisation (WHO). It is hoped that approval from the EMA could prompt a positive response from the WHO and allow the vaccine to become available from as early as 2016.

Sophie Biernaux, head of GSK’s malaria vaccine project, said: “This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria.”  

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Drugs | News

EMA agrees policy on clinical trial data publication

by Admin 16. June 2014 10:21

The European Medicines Agency (EMA) Management Board has taken an important step towards achieving increased transparency in the regulation of medicines in Europe.

The EMA has agreed the policy on publication of clinical trial data, together with more user-friendly amendments.

The policy, proposed by EMA Executive Director Guido Rasi, will not only allow the agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also allows the possibility to download, save and print the trial data for academic and non-commercial research purposes.

The wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalised with a view to formal written adoption by mid-July 2014. The policy will be effective from 1 October 2014. 

The agency will ensure that the policy will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation.

The agency has aimed to achieve the broadest possible consensus among its stakeholders and their often competing views and interests since the inception of its plans for the proactive publication of clinical trial data.

After an extensive initial consultation phase, the agency carried out a second round of targeted consultation in May 2014 that showed broad support for the policy, but highlighted concerns over the proposed view-on-screen-only access.

The policy takes the agency beyond its legal obligations and provides an unprecedented level of access to clinical trial data that are used as part of decision-making for new medicines.



EMA accepts accelerated marketing authorisation for IPF drug

by Admin 5. June 2014 10:05

Boehringer Ingelheim has announced that the European Medicines Agency (EMA) has accepted an accelerated marketing authorisation application for the review of nintedanib*, an investigational tyrosine kinase inhibitor (TKI) for the treatment of idiopathic pulmonary fibrosis (IPF).

The acceptance of this accelerated marketing authorisation application marks the beginning of the review process in the European Union for this potential new treatment.

Application for nintedanib* in IPF is supported by data from two identical Phase III trials involving more than 1,000 patients. Data show that nintedanib* slows disease progression by reducing the annual decline in lung function by half.

"IPF is a debilitating and fatal lung disease with limited treatment options available that can slow disease progression," said Dr Charles de Wet, UK Medical Director at Boehringer Ingelheim. "EMA approval will bring this much needed therapy one step closer to patients, who will ultimately benefit."

The marketing authorisation application for nintedanib* included results from two Phase III trials (recently published in the New England Journal of Medicine) with identical design, INPULSIS™-1 and INPULSIS™-2, which showed that nintedanib* significantly slowed disease progression in patients with IPF (p<0.001).

Data from the two 52-week trials demonstrate that nintedanib* met the primary endpoint by significantly reducing the annual decline in forced vital capacity by approximately 50 per cent compared to patients taking placebo.

Nintedanib*, taken as one capsule twice daily, is the first targeted treatment for IPF that has consistently demonstrated the ability to slow disease progression by significantly reducing decline in lung function with manageable side effects.

AbbVie drops data block lawsuit against EMA

by Admin 7. April 2014 14:03

The European Medicines Agency (EMA) has come to an agreement with AbbVie (ABBV) to drop a lawsuit designed to block the release of data on its blockbuster Humira.

ABBV filed suit last year claiming that the EMA's plans to disclose its trial results could do "serious and irreparable" damage to the company by exposing commercial secrets. The two parties have reached an agreement where selected clinical data will see the light but "sensitive" information will be kept private. 

The European Parliament recently voted in favour of new rules that would require sponsors to publish all clinical trial results within a year of the studies being completed, as part of a growing push to make more clinical trial results available to the public.  The change is expected to take effect in 2016 and will only apply to new trials.

The EMA still faces an outstanding appeal from InterMune (ITMN), which filed its protest at the same time over the same data issue.

A number of pharma companies have already made transparency pledges of their own. Johnson & Johnson (JNJ) and GlaxoSmithKline (GSK) have committed to data sharing, while Sanofi (SNY), Roche (RHHBY), Pfizer (PFE) and others have opened their vaults to varying extents. 

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Drugs | News

New HIV drug gains EMA approval

by JoelLane 25. November 2013 17:31

Tivicay-Tablets-web ViiV Healthcare, the HIV specialist company formed by GSK and Pfizer, has gained approval from the European Medicines Agency (EMA) for its antiretroviral Tivicay (dolutegravir).

Tivicay has been approved by the EMA for use in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults and adolescents aged 12 and older.

A single-tablet triple combination therapy consisting of Tivicay, Kivexa (abacavir) and Epzicom (lamivudine) was submitted for regulatory approval in Europe in October.

Tivicay is an HIV-1 integrase inhibitor, which blocks replication of the HIV type 1 virus by preventing its DNA from integrating with the DNA of human T-cells – the step that is responsible for establishing chronic infection.

The EMA approval is based on safety and efficacy data from four phase III clinical trials involving more than 2,500 patients, including young people, with comparators representing widely used anti-HIV drugs.

Dr John Pottage, Chief Medical Officer at ViiV Healthcare, said the approval “puts us a step closer to offering this new treatment option to people across Europe who are living with HIV.”

He acknowledged the contribution of patients to the drug’s success: “To make progress, thousands of patients have supported us through their participation in clinical development work and we recognise their commitment today with great gratitude.”

Final marketing authorisation from the European Commission is expected to follow in early 2014.

ViiV Healthcare is a global specialist HIV company established in 2009 by GSK and Pfizer. Shionogi joined as a 10% shareholder in 2012. The company aims to lead the field of HIV treatment by delivering new antiretroviral medicines.

Breast cancer drug gains EMA approval

by JoelLane 23. September 2013 16:51

Kadcyla web A new breast cancer drug developed by Roche in partnership with ImmunoGen has gained European Medicines Agency (EMA) approval.

Kadcyla (trastuzumab emtansine) has been approved as a monotherapy for adults with HER-2 positive, unresectable locally advanced or metastatic breast cancer who have been treated with Herceptin and a taxane.

Formerly known as T-DMI, Kadcyla combines Roche’s antibody drug Herceptin (trastuzumab) with a tumour-killing drug-conjugate from ImmunoGen.

The new injectable drug is expected to replace Herceptin as a blockbuster product in the breast cancer market, especially when the latter goes off patent and faces biosimilar competition.

Its price is more than twice that of Herceptin – but Kadcyla is predicted to earn as much as £5bn per year, following recent regulatory approvals in the US and Japan as well as the EU.

In the EMILIA phase III clinical trial, Kadcyla increased overall survival in women with HER2-positive metastatic breast cancer by 5.8 months compared with the standard therapies, with fewer side-effects.

Kadcyla costs $9,800 in the US, where Genentech (a subsidiary of Roche) has initiated a patient access scheme.

Genentech spokesman Ed Lang commented: “When pricing Kadcyla, we considered a variety of factors including the cost of the combination of Tykerb and Xeloda (approximately $10,460 per month), which is the current standard treatment in this line of therapy and the comparator in the pivotal EMILIA study.”


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