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FDA Watch: Approvals for Roche, Merck & Co.; designations for VistaGen, Clovis

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Oct. 5.


* Roche Holding AG's Hemlibra, for hemophilia A in patients who have developed a resistance to a certain blood clotting therapy. Hemlibra is now approved to treat hemophilia A in patients with and without factor VIII inhibitors.

* Merck & Co. Inc.'s Gardasil 9, to prevent certain cancers and diseases due to human papillomavirus in patients ages 27 to 45. The HPV vaccine was previously approved to treat patients 9 to 26 years old.

* Akcea Therapeutics Inc. and Ionis Pharmaceuticals Inc.'s Tegsedi, for polyneuropathy due to hereditary transthyretin-mediated amyloidosis in adults.

* Bose Corp.'s "self-fitting hearing aid" for adults with mild to moderate hearing loss.

* Paratek Pharmaceuticals Inc.'s Nuzyra, for adults with community-acquired bacterial pneumonia, and for acute skin and skin structure infections. The FDA previously granted Nuzyra priority review status.

* Antares Pharma Inc.'s Xyosted injection, as a testosterone replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone.

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

Priority review

* Karyopharm Therapeutics Inc.'s Selinexor, for penta-refractory multiple myeloma. The application's target action date is April 6, 2019.

Fast track

* VistaGen Therapeutics Inc.'s AV-101, for neuropathic pain due to damage or disease of the nervous system. AV-101 previously received fast-track status as a treatment for major depressive disorder.

Breakthrough therapy

* Clovis Oncology Inc.'s Rubraca, for previously treated adults with advanced prostate cancer. Rubraca is already approved to treat ovarian, fallopian tube and primary peritoneal cancers.

Other designations

* Orphan drug, for MediciNova Inc.'s MN-166, as an add-on therapy to Merck & Co.'s Temodar in patients with glioblastoma.

* Orphan drug, for Eidos Therapeutics Inc.'s AG10, to treat transthyretin amyloidosis.

* Rare pediatric disease, for Aeglea BioTherapeutics Inc.'s pegzilarginase, for Arginase 1 deficiency.

* Orphan drug, for Corcept Therapeutics Inc.'s relacorilant, for pancreatic cancer. Corcept is evaluating relacorilant in combination with Celgene Corp.'s Abraxane as a treatment for solid tumors.