This column summarizes New Drug Applications (NDAs) approved in the September-October 2016 timeframe. FDA approved 20 NDAs in these two months.
Only eight (40%) NDAs were for small molecules while the remaining 12 molecules (60%) were large molecules. Amgen and Genentech are the only companies with two NDA approvals in this period. They received approval for anticancer products. Two out of the 20 (10%) NDAs were combination dosage forms while there was one vaccine from protein sciences to treat influenza. Five out of 20 (25%) NDA’s were for treatment of various types of cancers. NDA’s were also awarded for rare diseases such as Crohn’s disease and Duchenne Muscular Dystrophy (DMD). Except for one intra-uterine system, the only other dosage forms approved were tablets (30%) and injections (65%). Certainly these are some of the new trends – approval of products with antibodies and higher usage of injectables. Kyleena (Levonorgestrol) is an intra-uterine system, which is a hormone-releasing IUD (intrauterine device) that prevents pregnancy for up to 5 years.
DMD is a rare genetic disorder characterized by progressive muscle deterioration and weakness. It is the most common type of muscular dystrophy. Exondys 51 was approved under the accelerated approval pathway, which was based on the surrogate endpoint of dystrophin increase in skeletal muscle observed in some Exondys 51-treated patients.
Invokamet XR, once daily, fixed dose combination therapy provides physicians needed flexibility for tailoring treatment to the needs of Type 2 diabetes patients, especially those with higher A1C levels.
Lucentis PFS is the first FDA approved prefilled syringe (PFS) product containing Ranibizumab. The PFS drug delivery offers ready-to-use options. It allows physicians to eliminate several steps in the preparation and administration process, including disinfecting the vial, attaching a filter needle, drawing the medicine from the vial using the needle, removing the filter needle from the syringe and replacing with an injection needle. With the Lucentis PFS, physicians attach the injection needle to the syringe and adjust the dose prior to administration.
FDA has approved Vermox Chewable (mebendazole chewable 500mg tablets) for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). Approval for Vermox Chewable came after the FDA granted Orphan Drug Designation and Priority Review for the new treatment, shortening the dossier review period from 10 months to six months.