Complete response, priority review, fast track
New Drug Application for suvorexant (Merck), an investigational agent for the treatment of insomnia. In the complete response letter, FDA advised Merck that: the efficacy of suvorexant has been established at doses of 10 mg to 40 mg in elderly and non-elderly adult patients; 10 mg should be the starting dose for most patients, and must be available before suvorexant can be approved; 15 mg and 20 mg doses would be appropriate in patients in whom the 10 mg dose is well-tolerated but not effective; and, for patients taking concomitant moderate CYP3A4 inhibitors, a 5 mg dose would be necessary.
In addition, FDA determined that the safety data do not support the approval of suvorexant 30 mg and 40 mg. Based on initial review of the letter, Merck has determined that additional clinical studies of suvorexant 10 mg will not be necessary. However, manufacturing studies will be required to advance the 10 mg dosage form. Merck will discuss with FDA whether additional studies will be required to support the 5-mg dose. As previously disclosed, both FDA approval and a separate scheduling determination by the US Drug Enforcement Administration are required before Merck can introduce suvorexant in the United States.
Supplemental new drug application for rivaroxaban (Xarelto, Janssen) to reduce the risk of stent thrombosis in patients with acute coronary syndrome. The company said that it is in ongoing discussions with FDA regarding this sNDA
ELND005 (Elan) for treatment of neuropsychiatric symptoms (NPS) in patients with moderate to severe Alzheimer’s disease.
Inhaled liposomal amikacin (Arikace, Insmed) for the treatment of non-tuberculous mycobacteria lung infections.
GM604 (Genervon) multi-target master regulator biotechnology drug for the treatment of ALS.
Pertuzumab (Perjeta, Genentech), trastuzumab (Herceptin, Genentech), and docetaxel for the treatment of patients with HER2-positive early-stage breast cancer.
Obinutuzumab, GA101 (Roche) for the treatment of chronic lymphocytic leukemia.
Metrelepin (Bristol-Myers Squibb and AstraZeneca) for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy.
ORPHAN DRUG DESIGNATION
SL-401 (Stemline Therapeutics) for the treatment of blastic plasmacytoid dendritic cell neoplasm.
RV001 (River Vision), a human monoclonal antibody teprotumumab for the treatment of active phase Graves Orbitopathy, also known as thyroid eye disease.
FIRST-TIME GENERIC APPROVAL
Metformin hydrochloride extended-release tablets in 500-mg and 1,000-mg strengths (equiv to Glumetza)
Oxymorphone hydrochloride extended-release tablets in the 5-mg, 10-mg, 20-mg, 30-mg, and 40-mg strengths (equiv to Opana ER)