Novartis, Roche. Biogen Lead Drug Approval News

A roundup of the latest drug approval news, including from the pharmaceutical majors, featuring news from Novartis, Roche, and Biogen.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 24, 2017 to Tuesday May 30, 2017.

FDA OKs Expanded Use for Novartis’ Lung Cancer Drug
Novartis has received approval from the US Food and Drug Administration (FDA) for the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.

Zykadia first received accelerated approval in 2014 for patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to crizotinib. In January 2017, the FDA granted Zykadia breakthrough therapy designation for the first-line treatment of patients with ALK-positive metastatic NSCLC with metastases to the brain, and priority review for first-line ALK-positive metastatic NSCLC.

Zykadia is an oral, selective inhibitor of anaplastic lymphoma kinase (ALK), a gene that can fuse with others to form an abnormal “fusion protein” that promotes the development and growth of certain tumors in cancers including NSCLC. Zykadia is currently approved in over 69 countries worldwide.

Source: Novartis

Roche Gets FDA OK for New Use for Arthritis Drug
The US Food and Drug Administration (FDA) has approved Roche’s Actemra/RoActemra (tocilizumab) ) subcutaneous injection for the treatment of giant cell arteritis (GCA), a chronic and severe autoimmune condition. Actemra/RoActemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra/RoActemra since the medicine was launched in 2010.

GCA can cause severe headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke, according to information from Roche.

Actemra/RoActemra is an anti-IL-6 receptor biologic, available in both intravenous and subcutaneous formulations, for the treatment of adult patients with moderate-to -evere active rheumatoid arthritis.

Source: Roche

Biogen Receives European OK for MS Drug
The European Commission (EC) has granted a standard marketing authorization for Biogen’s Fampyra (prolonged-release fampridine tablets) for walking improvement in people with multiple sclerosis (MS). The drug had received EC’s conditional marketing authorization in 2011, and Biogen conducted additional clinical studies to support standard marketing approval. 

Biogen has a license from Acorda Therapeutics, Inc. to develop and commercialize Fampyra in all markets outside the United States.

Source: Biogen

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