Biogen, Merck KGaA, Novartis and Sanofi Lead Pipeline News

A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Biogen, Merck KGaA, Novartis, and Sanofi.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday October 26, 2016 to Tuesday November 1, 2016.

FDA, EMA Accept Biogen’s Application for Spinal Muscular Atrophy Drug
Biogen’s new drug application for nusinersen, an investigational treatment for spinal muscular atrophy (SMA), has been accepted by the US Food and Drug Administration (FDA) for priority review, and its marketing authorization application for the drug has been validated by the European Medicines Agency (EMA). Nusinersen had previously been granted accelerated assessment status by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The regulatory review process for these applications has now been initiated in both the US and European Union (EU).

Biogen intends to market nusinersen under the brand name Spinrazatm. This name has been conditionally accepted by the FDA and the CHMP and is expected to be confirmed upon approval. Biogen said it is initiating regulatory filings in other countries in the coming months.

Nusinersen is an investigational antisense oligonucleotide therapy for the treatment of SMA that was discovered and developed by Ionis Pharmaceuticals, a Carlsbad, California-headquartered pharmaceutical company focused on antisense therapeutics. Biogen exercised its option to worldwide rights to nusinersen in August 2016. Antisence oligonucleotides are short synthetic strings of nucleotides designed to selectively bind to target RNA and regulate gene expression, according to the company.

Biogen and Ionis Pharmaceuticals have support from the following organizations for nusinersen: Cure SMA, Muscular Dystrophy Association, and SMA Foundation, and have licensed intellectual property from Cold Spring Harbor Laboratory and the University of Massachusetts Medical School.

Source: Biogen

EMA Accepts Merk KGaA’s Cancer-Drug Application for Review
The European Medicines Agency has validated for review Merck KGaA’s and Pfizer’s marketing authorization application for avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody being developed for the treatment of metastatic Merkel cell carcinoma (MCC), an aggressive type of skin cancer. Avelumab received an orphan drug designation from the European Commission for MCC. Avelumab Is currently not approved for any indication in any market, according to Merck KGaA. In November 2014, Merck KGaA and Pfizer formed a strategic alliance to co-develop and co-commercialize avelumab as part of a larger immuno-oncology pact. 

Source: Merck

Novartis Gets FDA Priority Review for Breast-Cancer Drug
The US Food and Drug Administration has accepted Novartis’ new drug application for ribociclib, its ant-cancer drug candidate, and has granted ribociclib priority review as a first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole. FDA priority review designation requires the agency to take action on an application within six months of its filing date compared to ten months under standard review.

Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that slows the progression of cancer by inhibiting two proteins called cyclin dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly, according to Novartis. Ribociclib is not approved for any indication in any market at this time, Novartis said. The drug candidate was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals, a Cambridge, UK-based biotechnology company.

Source: Novartis

Sanofi, Regeneron Get Complete Response Letter from FDA for Arthritis Drug
Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based pharmaceutical company, have received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding a biologics license application (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for treating adult patients with moderately to severely active rheumatoid arthritis.

The CRL refers to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in the Haute-Normandie region in France where sarilumab is filled and finished. Satisfactory resolution of these deficiencies is required before the BLA can be approved. Sanofi submitted a corrective action plan to the FDA and is implementing the corrective actions specified in that plan. The CRL does not identify any concerns relating to the safety or efficacy of sarilumab.

Sanofi and Regeneron said that they remain committed to the development of sarilumab. If approved by the FDA, sarilumab would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.

Source: Sanofi 

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