This column summarizes approved New Drug Applications (NDAs) in 3Q15. In this quarter, FDA approved 38 NDAs.
Twenty-five (65.8%) NDAs were for small molecules while the remaining 13 (34.2%) were for large molecules. Most of the large molecules were used in the cancer therapy. In this quarter, 18 companies (47.4%) receiving NDA approvals were large companies and the remaining 20 companies (52.6%) were mid-sized and small companies. Six drug molecules were granted the Orphan Drug status (15.8%). Boehringer Ingelheim (BI) received three NDAs in this quarter, while Bristol-Myers Squibb, Merck and Novo Nordisk received two NDA’s, each. Tablets, capsules and injections were the preferred dosage forms except Onsolis (buccal film), Enstilar (foam), Dyanavel XR (oral suspension) and Veltassa (oral suspension). Six out of 38 (15.8%) NDAs were combination dosage forms.
Spritam tablets utilize Aprecia’s proprietary ZipDose® Technology platform, a ground-breaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.
Addyi (Flibanserin) is a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) for the treatment of hypoactive sexual desire disorder in premenopausal women.
Synjardy is now the fifth FDA-approved medicine to emerge from the BI/Lilly’s diabetes alliance pipeline in the last four years. Empagliflozin removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin lowers glucose production by the liver and its absorption in the intestine.
Repatha, is the second drug approved in a new class of drugs known as PCSK9 inhibitors to dramatically lower LDL cholesterol levels. Aptiom (supplemental NDA) is the only exclusively once-daily non-extended release antiepileptic drugs (AEDs), which can be used alone or in combination with other AEDs in the treatment of partial-onset seizures. Emend is the first and only NK1 receptor antagonist to be approved for the prevention of acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV) in patients 12 to 17 years of age and patients less than 12 years who weigh at least 30 kg. Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary Orotic aciduria.
Nuwiq is the first B-domain deleted recombinant Factor VIII (FVIII) derived from a human cell-line, not chemically modified or fused with another protein, designed for the treatment of patients with Hemophilia A, congenital FVIII deficiency. Veltassa (Patiromer) has received a boxed warning by FDA because it binds with many other orally administered drugs. Patients are advised to wait for at least six hours between taking Patiromer and any other oral drugs.