This column summarizes New Drug Applications (NDAs) approved in the November-December 2016 and January 2017. FDA approved 30 NDAs in these three months.
Sixteen (53.3%) NDA approvals were for small molecules while the remaining 14 molecules (46.6%) were large molecules. Four of the 14 large molecules were vaccines and hormonal therapies, while the remaining 10 were predominantly for cancer treatment. Teva received a total of three NDA’s in these three months, two of which are inhalation powders consisting of fluticasone propionate. BI, Novo Nordisk and Janssen Pharmaceuticals are the companies with two NDA approvals in this period. Five out of 30 of the NDAs were combination dosage forms. Five out of 30 NDA’s were for treatment of diabetes Type 2, while three NDA’s were for the treatment of asthma. The types of dosage forms approved were – tablets and capsules: 10 (33.3%), injections: 12 (40%), creams and ointments: 2 (6.6%), sprays and inhalers: 4 (13.3%) and vaginal insert: 1 (3.3%).
Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 300 mg.
Xultophy (Novo Nordisk) and Soliqua (Sanofi) received approvals for the treatment of diabetes Type II. Both are combination dosage forms containing insulin analogues and the second drug being liraglutide and lixisenatide, respectively. In these three months, five products were approved to treat diabetes.
Spinal muscular atrophy is a hereditary disease that causes weakness and muscle wasting because of the loss of lower motor neurons controlling movement. There is wide variability in age of onset, symptoms and rate of progression. Spinraza is approved for use across the range of spinal muscular atrophy patients. It is administered as an injection in the fluid surrounding the spinal cord.
Arymo ER is the first approved product developed using Egalet's proprietary Guardian™ Technology - a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist - creating tablets that are difficult to manipulate for the purpose of misuse and abuse.