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TOKYO and GODDELIES — Astellas Pharma on Monday announced an acquisition that will expand the company’s late-stage small-molecule pipeline. Astellas will be acquiring drug discovery company Ogeda for as much as €800 million, including a €500 million initial payment. Ogeda shareholders will be eligible for an additional €300 million as the company attains certain clinical milestones for its lead investigational candidate fenzolinetant.

MAPLE GROVE, Minn. — The Food and Drug Administration on Thursday approved Upsher-Smith Laboratories’ two supplemental new drug applications for Qudexy (toprimate) Extended-Release Capsules for use as prophylaxis of migraine headache in adults and adolescents 12 years of age and older.

Topiramate is the molecule that neurologists prescribe most frequently for the prevention of migraines, and the American Academy of Neurology and the American Headache Society have given topiramate a “top tier” rating for migraine prevention in adults.

WASHINGTON — The Food and Drug Administration approved Genentech’s Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (PPMS).

This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional. 

WASHINGTON — The Food and Drug Administration on Tuesday approved Regeneron’s Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

WASHINGTON — Tesaro on Monday announced the Food and Drug Administration approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy. According to Tesaro, an oncology-focused biopharmaceutical company, Zejula is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing.

SOUTH SAN FRANCISCO, Calif. — The U.S. Food and Drug Administration granted Breakthrough Therapy Designation status to Genentech’s Rituxan, intended for the treatment of pemphigus vulgaris, a painful, disfiguring and potentially fatal autoimmune disease characterized by progressive blistering of skin and/or mucous membranes.

WASHINGTON — The U.S. Food and Drug Administration on Thursday granted accelerated approval to Merck KGaA and Pfizer's EMD Serono unit's Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer.