Roche, Sanofi, and Teva Gain FDA Approval for NMEs

Pharmaceutical majors Roche, Sanofi, and Teva Pharmaceutical Industries have gained approval from the US Food and Drug Administration (FDA) for their respective new molecular entities: Roche’s Ocrevus (ocrelizumab), a drug for treating multiple sclerosis (MS); Sanofi’s Dupixent (dupilumab), an eczema drug; and Teva’s Austedo (deutetrabenazine), an orphan drug for treating chorea associated with Huntington’s disease (HD).

Roche’s Ocrevus, is specifically approved for treating both relapsing and primary progressive forms of MS. Ocrevus is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, according to Roche. Roche’s marketing authorization application (MAA) for the drug in Europe has also been validated by the European Medicines Agency (EMA) and is currently under review.

Sanofi and its partner, Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, received FDA approval for Dupixent under priority review for treating moderate-to-severe atopic dermatitis (AD), the most common form of eczema. The drug is indicated for treating the disease when it is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent is a human monoclonal antibody designed to specifically inhibit overactive signaling of two proteins, interleukin-4 and interleukin-13, believed to be drivers of the persistent underlying inflammation in AD, according to Sanofi. Sanofi Genzyme, the specialty care global business unit of Sanofi, and Regeneron will market Dupixent in the US, which is expected to be available in the US in April 2017. The EMA accepted for review Sanofi’s and Regeneron’s MAA for Dupixent in December 2016 for treating uncontrolled moderate-to-severe AD.

Teva’s Austedo was approved by the FDA for treating chorea associated with Huntington’s disease. The drug was previously granted orphan drug designation by the FDA.

Source: Roche, Sanofi, and Teva Pharmaceutical Industries

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