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.
* 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.
|FDA headquarters in Silver Spring, Md.|
|Source: Associated Press|
* 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.
* 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.