This column summarizes New Drug Applications (NDAs) from May 2015 to July 2015. In this quarter, FDA approved 26 NDAs.
Nineteen (73.1%) NDAs approved were for small molecules while the remaining 7 molecules (26.9%) were for large molecules. In this quarter, the 10 companies (38.5%) receiving NDA approvals were large companies and the remaining 16 companies (61.5%) were midsized and small companies. An increased number of small companies were successful in the race in this quarter. Only Novartis and Bayer obtained more than one NDA approval. Seven (26.9 %) of the total NDA’s were combination dosage forms. Technivie by AbbVie consists of a combination of three drugs: Ombitasvir, Paritaprevir and Ritonavir. Tablets (57.7%) and injections (19.6%) were the preferred dosage forms. Sprinkle capsules such as Qudexy XR are intended to be sprinkled on soft food especially for the ease of administration in pediatric patients.
Seven Novel New Drugs (NNDs) were approved in this quarter. NNDs are innovative products that serve previously unmet medical needs or otherwise significantly help to advance patient care and public health. These NNDs are – Viberzi, Kengreal, Orkambi, Entresto, Odomzo, Praluent, and Daklinza. Out of these seven, three were first in class (FIC). FICs are drugs often having mechanisms of action different from those of existing therapies. Some of the notable drugs are: Entresto to treat heart failure; Praluent to treat certain patients with hard to treat heterozygous familiar hypercholesterolemia; and Viberzi to treat patients who have irritable bowel syndrome diarrhea. Entresto, Orkambi and Viberzi received priority review and fast track approvals.
Orkambi (Lumacaftor 200 mg/Ivacaftor 125 mg) is approved to treat cystic fibrosis (CF) in patients 12 years and older, who have the F508del mutation, which causes the production of an abnormal protein that disrupts how water and chloride are transported in the body. Having two copies of this mutation (one inherited from each parent) is the leading cause of CF.
Promacta (eltrombopag) is a man-made form of a protein that increases production of platelets (blood-clotting cells) in the body. Eltrombopag can lower the risk of bleeding by increasing platelets in the blood. Promacta is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood.
Tuxarin ER (chlorpheniramine + codeine) was co-developed by Spriasco and Nexgen Pharma. It is the first product to offer long-lasting cough suppression with a safer opiate that is less prone to respiratory distress while minimizing serious risk of dosing errors in patients 18 years and older.
Rexulti was discovered by Otsuka and co-developed with Lundbeck. It is co-marketed by these two companies.
Adapalene is a synthetic naphthoic acid derivative with retinoid activity. It helps the skin to renew itself. Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.