Approvals and designations made by the U.S. Food and Drug Administration for the week ended Oct. 4.
Approvals
* Gilead Sciences Inc.'s Descovy to prevent sexually acquired HIV infections in adults and adolescents who weigh at least 77 pounds, do not already have HIV and are at risk for sexual infection.
* AstraZeneca PLC's Fasenra for self-administration by patients with severe eosinophilic asthma using an auto-injector pen.
* Johnson & Johnson's Invokana to reduce the risk of end-stage kidney disease, worsening of kidney function, cardiovascular death and hospitalization for heart failure in certain adults with type 2 diabetes and diabetic kidney disease.
* Ultragenyx Pharmaceutical Inc. and Tokyo-based Kyowa Kirin Co. Ltd.'s Crysvita for children as young as six months old with X-linked hypophosphatemia, or XLH. The drug was initially approved to treat XLH in adults and children ages 1 and older.
FDA headquarters in Silver Spring, Md. |
Complete response letters
* AstraZeneca's PT010, an inhaled triple-combination therapy for chronic obstructive pulmonary disease. The Cambridge, U.K.-based company plans to coordinate with the FDA regarding the next steps, including submitting the recent results of a second phase 3 study dubbed Ethos.
Priority review
* Merck & Co. Inc.'s Dificid for clostridium difficile infections in children older than six months.
* Merck & Co.'s Dificid in an oral suspension form for clostridium difficile infections in older patients or those unable to tolerate solid forms of medicine.
Fast-track
* Geron Corp.'s imetelstat for patients with intermediate or high-risk myelofibrosis whose disease has returned or is resistant to a certain type of enzyme activity inhibitor.
* Amryt Pharma PLC's AP101 for epidermolysis bullosa.
Breakthrough therapy
* Johnson & Johnson's Zejula for BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer.
Other designations: orphan
* Verastem Inc.'s Copiktra

