A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Biogen, AbbVie, Novo Nordisk, Sanofi, and Shire.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, February 28, 2017 to Tuesday, March 6, 2017.

Biogen, AbbVie Voluntarily Withdraw MS Drug Zinbryta from Global Market
Biogen and AbbVie have voluntarily withdrawn Zinbryta (daclizumab), a multiple sclerosis drug, from markets worldwide.

Zinbryta was approved in May 2016 in the US and is currently available in the European Union, US, Switzerland, Canada, and Australia. Biogen reported 2017 Zinbryta sales of $53 million. AbbVie did not disclose Zinbryta sales in its 2017 full-year earnings report.

In a March 2, 2018 statement, the European Medicines Agency announced that it started an urgent review of the multiple sclerosis medicine Zinbryta following seven cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain.

Biogen also released a statement on March 2, 2018. “Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated,” said Biogen in a March 2, 2018 statement. “Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for Zinbryta.”

Biogen said it plans to continue to work with regulatory authorities in the withdrawal of the product and with healthcare providers worldwide in their support of Zinbryta patients.

Source: Biogen

Novo Nordisk Submits to FDA, EMA for Approval of Hemophilia Drug
Novo Nordisk has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for N8-GP, an extended half-life factor VIII for treating hemophilia A.

N8-GP is a glycopegylated B-domain truncated recombinant factor designed for prolonged half-life. A site-specific glycopegylation is within the truncated B-domain. When activated by thrombin at the site of injury, the B-domain containing the peglyated moiety (PEG) is cleaved off, generating Factor VIII, which is similar in structure to native Factor VIIIa, according to Novo Nordisk.

Source: Novo Nordisk

FDA Accepts Sanofi’s sBLA for Asthma Drug Dupixent
The US Food and Drug Administration (FDA) has accepted Sanofi’s supplemental biologics license application of Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma.

Dupixent is a human monoclonal antibody designed to inhibit signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two signaling proteins (cytokines) that contribute to Type II inflammation in moderate-to-severe asthma, according to information from Sanofi.

The potential use of Dupixent in asthma is currently under clinical development and the safety and efficacy for this use have not been fully evaluated by any regulatory authority. Per the Prescription Drug User Fee Act, the target action date for this indication by the FDA is October 20, 2018.

In March 2017, the FDA approved Dupixent in the US for treating adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent is also approved for use in certain patients with moderate-to-severe atopic dermatitis in a number of other countries, including the countries of the European Union, Canada, and Japan.

Source: Sanofi

FDA Accepts Shire’s NDA for Gastrointestinal Drug
The US Food and Drug Administration (FDA) has accepted Shire’s submission of a new drug application (NDA) for prucalopride, a once-daily treatment for chronic idiopathic constipation (CIC) in adults.

The FDA is expected to provide a decision on or around December 21, 2018, according to the company.

Prucalopride is approved and available in the European Union, where it is marketed by Shire as Resolor, and it is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief. It is also available in several other countries outside of Europe.

Source: Shire