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FDA Watch: Designations for Merck & Co., Sanofi, Fibrocell Science


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FDA Watch: Designations for Merck & Co., Sanofi, Fibrocell Science

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Sept. 7.

Complete response letters

* GlaxoSmithKline PLC's Nucala, as add-on treatment to reduce exacerbations of symptoms of chronic obstructive pulmonary disease. The regulator is seeking more data to support an approval.

Priority review

* Merck & Co. Inc.'s Keytruda, for adults and children with Merkel cell carcinoma whose cancers have spread across the body.

* Sanofi's Cablivi, for adults experiencing an episode of thrombotic thrombocytopenic purpura, a rare blood clotting disorder.

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

Fast track

* Fibrocell Science Inc.'s FCX-013, for moderate to severe localized scleroderma. The FDA previously granted the drug orphan drug designation and rare pediatric disease designation for certain types of localized scleroderma.

Breakthrough therapy

* Amgen Inc. and AstraZeneca PLC's tezepelumab, for severe asthma without an eosinophilic phenotype.

* Loxo Oncology Inc.'s Loxo-292, for patients with metastatic RET-fusion-positive non-small cell lung cancer who require systemic therapy and whose cancers have progressed following platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy; and for patients with RET-mutant medullary thyroid cancer who require systemic therapy, whose cancers have progressed following prior treatment and have no acceptable alternative treatment options.

* Pfizer Inc.'s PF-06651600, for alopecia areata, an autoimmune skin disease that causes hair loss.