This column summarizes New Drug Applications (NDAs) approved in May-June 2016. FDA approved 24 NDAs in these two months.
Fifteen (62.5%) NDAs were for small molecules while the remaining nine molecules (37.5%) were large molecules. The use of large molecules for treatment of diseases such as cancer and HIV has increased recently. In this quarter, many mid-sized and small companies received NDA approvals. Eisai and AbbVie are the only companies with two NDA approvals in this period. Four out of 24 (16.7%) of NDAs were combination dosage forms. Three out of 24 NDA’s were for treatment of various types of cancers, while two of each NDA’s were for the treatment of diabetes type 2, diagnosis and investigation, prophylaxis. The types of dosage forms approved were – tablets and capsules: nine (36%), injections: ten (40%), suspension: two (8%), powder: one (4%), gel: one (4%), implant: one (4%) and nasal spray: one (4%).
Fycompa™ is the first and only FDA approved non-competitive AMPA receptor antagonist for the treatment of epilepsy and seizures.
FDA approved Genentech's Tecentriq® for the treatment of bladder and non-small cell lung cancer. This is the first product in its class (PD-1/PD-L1 inhibitors) approved to treat urothelial carcinoma.
FDA approved Probuphine® by Titan Pharmaceuticals, which is the first buprenorphine implant for the maintenance treatment of opioid dependence.
Axumin™ (Fluciclovine F 18) is the first FDA-approved F18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer. Specifically, it is useful to detect cancer in patients with low prostate specific antigen (PSA) levels
FDA approved Zinbryta™ (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta™ is a long-acting injection that is self- administered by the patient monthly.
Netspot is the first kit approved by FDA for the preparation of gallium Ga 68 dotatate injection. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition. DOTA-TATE is an amide of the acid DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid), which acts as a chelator for a radionuclide. The FDA granted Priority Review and orphan drug designations for Netspot.
Rayaldee® is the first product to receive the FDA approval for the treatment of adults with secondary hyperparathyroidism associated with vitamin D insufficiency in stage 3 to 4 chronic kidney disease.
Humira® is the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and Panuveitis. This is the 10th approved indication for Humira.
Invokamet®, Jentadueto®, Byvalson™, Epclusa® and Kovanaze™ are the combination drug products to get FDA approval.
Ameluz® is Biofrontera’s first prescription drug.