This column summarizes New Drug Applications (NDAs) approved in January-February 2015. In these two months, FDA approved 28 NDA’s.
Twenty one (75 %) NDA’s were for small molecules while the remaining seven molecules (25%) were large molecules. Ferric pyrophosphate citrate (Triferic), from its name, does not seem to be a typical large molecule. It was considered as a large molecule because of its molecular weight (1313 daltons). In this period, sixteen companies (47.4%) receiving NDA approvals were large companies and the remaining twelve companies (57%) were mid-sized and small companies. Only Lenvatinib was granted Orphan Drug status (3.5%). Tablets (21.4%), capsules (28.6%) and injections (28.6%) were the preferred dosage forms, though an intrauterine device (IUD) to treat UTI’s was introduced as well. Two products were introduced as extended release capsules. Nine out of twenty-eight (32.1%) NDA’s were combination dosage forms of which Rytary and Duopa both have a combination of Carbidopa and Levodopa. Evotaz and Prezcobix both have a combination of a protease inhibitor and pharmacokinetic enhancer, where the pharmacokinetic enhancer is the same (Cobicistat). A trend has been observed to combine two different drug molecules which have individual NDA’s approved and file it as a new NDA. Four such fixed-dose combinations were approved in this period. Bristol-Myers Squibb’s Evotaz contains a fixed combination of Atazanavir and Cobicistat. Prezcobix is a fixed combination of Cobicistat and Darunavir. Both are used to treat HIV infection.
Seven out of the 28 (25%) NDA’s received approval either as a new formulation, a new indication, an altered patient population, or as a new dosage form for the same drug. These molecules had received NDAs in the previous quarters.
FDA approved a new formulation of Zohydro ER (hydrocodonebitartrate) Extended-Release Capsules, CII, with BeadTek™ technology. BeadTek™ incorporates well-known pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents. It is a formulation technology designed to provide abuse-deterrent properties without changing the release properties of hydrocodone.
Glyxambi is the first and only diabetes treatment in the U.S. to combine dual mechanisms of action. Sodium glucose co-transporter-2 (SGLT2) inhibitor removes glucose through the urine by blocking blood glucose re-absorption in the kidney. A dipeptidyl peptidase-4 (DPP-4) inhibitor works by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.
Ibrance developed by Pfizer consists of Palbociclib which inhibits molecules known as cyclin-dependent kinases (CDKs) 4 and 6, that are involved in promoting the growth of cancer cells.
Lenvima, approved for a rare type of thyroid cancer, was reviewed under the FDA’s priority review program. This program provides an expedited review of drugs that, if approved, would provide significant improvement in safety or effectiveness in the treatment of a serious condition.
Liletta, a small, flexible plastic T-shaped levonorgestrel-releasing intrauterine system was approved by FDA for use by women to prevent pregnancy for up to three years. Liletta works by continuously releasing levonorgestrel, a progestin, to prevent pregnancy.