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FDA Watch: Approvals for Roche, Novo Nordisk, Eli Lilly

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 8.


* Roche Holding AG's Avastin, for glioblastoma that progressed following prior therapy. The full approval was granted to Roche unit Genentech Inc. The drug, which previously secured provisional approval, is already approved to treat metastatic colorectal cancer, advanced nonsquamous non–small cell lung cancer and advanced cervical cancer.

* Novo Nordisk A/S' Ozempic, for adults with type 2 diabetes mellitus. The company will conduct a pediatric trial for the drug as part of the post-approval requirements.

* Eli Lilly and Co.'s Taltz injection, for adults with active psoriatic arthritis. The drug is already approved to treat certain adults with moderate to severe plaque psoriasis.

* Dr. Reddy's Laboratories Ltd.'s Impoyz cream, for moderate to severe plaque psoriasis in patients 18 years of age or older. Encore Dermatology Inc. is licensed to commercialize the product in the U.S.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Priority review

* Clovis Oncology Inc.'s Rubraca, for recurrent ovarian cancer. The application's Prescription Drug User Fee Act date is April 6, 2018.

Other designations

* Rare pediatric disease, for CTD Holdings Inc.'s Trappsol Cyclo, for Niemann-Pick disease type C. The treatment, which previously secured orphan drug designations in the U.S. and the European Union, is undergoing a phase 1 trial in the U.S. and a phase 1/2 trial in Europe and Israel.

* Orphan drug, for Ovid Therapeutics Inc.'s TAK-935/OV935, for Dravet syndrome. The company is developing the drug under a collaboration with Takeda Pharmaceutical Co. Ltd.

* Orphan drug, for Seres Therapeutics Inc.'s SER-287, for pediatric patients with ulcerative colitis. The company is expecting results from a phase 1b trial of the drug in early 2018.