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FDA Watch: Approvals for Pfizer; designations for Bristol-Myers, Merck & Co.


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FDA Watch: Approvals for Pfizer; designations for Bristol-Myers, Merck & Co.

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 15.


* Pfizer Inc.'s Xeljanz, for certain adult patients with active psoriatic arthritis. Xeljanz is already approved to treat adult patients with moderate to severe active rheumatoid arthritis.

* Pfizer's biosimilar Ixifi, for rheumatoid arthritis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The drug is a biosimilar version of Johnson & Johnson's Remicade and was approved for all eligible indications of the reference product.

* Sanofi's Admelog, for adults with type 2 diabetes as well as adults and children with type 1 diabetes. Admelog, or insulin lispro injection, is similar to Eli Lilly and Co.'s Humalog, which is approved in the U.S.

* GlaxoSmithKline plc's Nucala, for eosinophilic granulomatosis with polyangiitis, formerly known as Churg-Strauss syndrome. Nucala is already approved to treat severe asthma with an eosinophilic phenotype.

* Aclaris Therapeutics Inc.'s Eskata, for raised seborrheic keratoses. The company expects to launch Eskata, a topical solution, in spring 2018.

* Allergan plc's CoolSculpting technology, for improving the appearance of lax tissue in combination with submental fat, or double chin. The approval was granted to Allergan unit Zeltiq Aesthetics Inc.

* Boston Scientific Corp.'s Vercise Deep Brain Stimulation System, for symptoms of Parkinson's disease. The Vercise system first launched in Europe in 2012.

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

Priority review

* Bristol-Myers Squibb Co.'s Opdivo-Yervoy combination, for intermediate- and poor-risk patients with advanced renal cell carcinoma. The application's target action date is April 16, 2018.

* Merck & Co. Inc.'s Keytruda, for primary mediastinal B-cell lymphoma. The application's target action date is April 3, 2018.

Fast track

* BioVie Inc.'s BIV201, for refractory ascites due to liver cirrhosis. The patented orphan drug candidate is being evaluated in a phase 2a trial.

Other designations

* Orphan drug expansion, for Alnylam Pharmaceuticals Inc.'s patisiran, for transthyretin-mediated amyloidosis. The drug's prior designation was for familial amyloidotic polyneuropathy. The company is developing patisiran under a collaboration with Sanofi's Sanofi Genzyme.