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FDA Watch: Approvals for Pfizer, Eli Lilly; designations for Novartis, Eisai

Approvals and designations made by the U.S. Food and Drug Administration for the week ended June 1.

Approvals

* Pfizer Inc.'s Xeljanz, for moderate to severe ulcerative colitis. The drug is already approved to treat rheumatoid arthritis and psoriatic arthritis.

* Eli Lilly and Co. and Incyte Corp.'s Olumiant, for certain adults with rheumatoid arthritis. The FDA approved Olumiant with a boxed warning for the risk of serious infections leading to hospitalization or death.

* Intuitive Surgical Inc.'s da Vinci SP surgical system, for urologic surgeries appropriate for a single port approach.

* Kitov Pharma Ltd.'s Consensi, to treat pain from osteoarthritis and hypertension. The tablets consist of celecoxib and amlodipine besylate, which are already approved to treat osteoarthritis and hypertension, respectively.

* Terumo Corp.'s LVIS and LVIS Jr. stents, for use in stent-assisted coil embolization of intracranial aneurysms. The FDA granted Terumo premarket approval.

* HumanOptics AG's CustomFlex Artificial Iris, a surgical eye implant for certain patients with a missing or damaged iris.

* TherapeuticsMD Inc.'s Imvexxy, for moderate to severe dyspareunia, or vaginal pain associated with sexual activity.

* TransEnterix Inc.'s Senhance Surgical System, for laparoscopic inguinal hernia and laparoscopic cholecystectomy procedures. The company received 510(k) clearance.

* T2 Biosystems Inc.'s T2Bacteria Panel, which detects specific sepsis-causing bacterial pathogens in whole blood specimens.

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

Priority review

* Novartis AG's Promacta, combined with standard immunosuppressive therapy, for severe aplastic anemia. Promacta is already approved to treat certain patients with severe aplastic anemia and chronic immune thrombocytopenia.

* Eisai Co. Ltd.'s Fycompa, for children ages 2 to 12 with partial onset seizures or primary generalized tonic-clonic seizures. Fycompa is already approved to treat certain seizures in epilepsy patients aged 12 and older.

* Sage Therapeutics Inc.'s brexanolone, for postpartum depression. The application's target action date is Dec. 19.

* Catalyst Pharmaceuticals Inc.'s Firdapse, for Lambert-Eaton myasthenic syndrome. The application's target action date is Nov. 28.

* Astellas Pharma Inc.'s gilteritinib, for adults with FLT3 mutation-positive acute myeloid leukemia. The application's target action date is Nov. 29. The FDA previously granted gilteritinib orphan drug and fast-track status.

* Loxo Oncology Inc.'s larotrectinib, for certain patients whose solid tumors have the neurotrophic tyrosine receptor kinase gene fusion. The application's target action date is Nov. 26. The FDA previously granted larotrectinib breakthrough therapy, rare pediatric disease and orphan drug status.

Fast track

* Curis Inc.'s fimepinostat, for certain patients with diffuse large B-cell lymphoma.

Breakthrough therapy

* Pfizer's Xalkori, for patients whose non-small cell lung cancer had the MET exon 14 gene alteration, as well as certain patients with anaplastic large cell lymphoma. The drug is already approved to treat certain lung cancer patients.