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FDA Watch: Approvals for J&J, AstraZeneca; designations for Roche, Pfizer

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Feb. 16.

Approvals

* Johnson & Johnson's Erleada, for nonmetastatic, castration-resistant prostate cancer. The approval was granted to the company's Janssen Pharmaceutical Companies.

* AstraZeneca PLC's Imfinzi, to reduce the risk of cancer progression among certain patients with non-small cell lung cancer. The drug is already approved to treat locally advanced or metastatic urothelial carcinoma.

* Abiomed Inc.'s Impella heart pumps, for heart failure associated with cardiomyopathy leading to cardiogenic shock. The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are already approved to treat acute myocardial infarction cardiogenic shock and post-cardiotomy cardiogenic shock.

* Vertex Pharmaceuticals Inc.'s tezacaftor-Kalydeco combination therapy Symdeko, for cystic fibrosis. Kalydeco is already approved to treat cystic fibrosis in certain patients aged 2 and up.

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

Complete response letters

* Apricus Biosciences Inc.'s Vitaros, for erectile dysfunction. The FDA rejected the application due to chemistry, manufacturing and safety issues.

Priority review

* Roche Holding AG's Rituxan, for pemphigus vulgaris. The FDA previously granted Rituxan breakthrough therapy and orphan drug designations. The drug is already approved to treat other autoimmune diseases.

* Agios Pharmaceuticals Inc.'s ivosidenib, for certain patients with acute myeloid leukemia. The application's target action date is Aug. 21.

* Amicus Therapeutics Inc.'s migalastat HCl, for Fabry disease in certain patients aged 16 and up. The application's target action date is Aug. 13. The FDA previously granted migalastat HCl fast track and orphan drug designations.

Breakthrough therapy

* Pfizer Inc.'s PF-04965842, for moderate to severe atopic dermatitis.

Other designations: orphan drug

* AstraZeneca and Merck & Co. Inc.'s selumetinib, to treat neurofibromatosis type 1. The FDA previously granted selumetinib orphan drug designation for the adjuvant treatment of differentiated thyroid cancer.

* Arrowhead Pharmaceuticals Inc.'s ARO-AAT, to treat a rare genetic liver disease associated with alpha-1 antitrypsin deficiency. The company applied to begin first-in-human studies of the drug in Dec. 2017.

* ProMetic Life Sciences Inc.'s inter-alpha-inhibitor-proteins, to treat necrotizing enterocolitis.

* Abeona Therapeutics Inc.'s ABO-202, to treat infantile Batten disease. The drug is set to undergo clinical trials in 2018.