This quarterly review on New Drug Applications contain data for applications approved during the fourth quarter of 2020, which includes New Molecular Entities (NMEs), new biologics, etc. A total of 31 applications were approved by FDA during these three months. Following are the different percentages based on the type of application – Type I (New molecular entity, 29.0%), Type 3 (New dosage form, 19.4%), Type 4 (New combination, 6.5%), Type 5 (New formulation or manufacturer, 19.4%), Type 9 (New distinct indication consolidated with original NDA, 3.1%), Type 10 (New distinct indication not consolidated with original NDA, 6.5%) and BLA (Biologics license application, 16.1%). There were nine new molecules filed as NDAs, but only one was developed by a large pharmaceutical company with the remaining eight from small to medium pharmaceutical companies. Is it an indication of innovations taking place in small pharma?
The last quarter of 2020 approvals were divided into six different dosage forms. Following are the percentages of those dosage forms – 19.3% oral tablets, 45.2% injectables, 9.7% oral capsules, 9.7% oral liquids, 6.4% unknown, and the remaining 9.7% include ophthalmic suspensions, inhalation powders and topical ointments.
Two drugs, Ebanga and Inmazab, were approved to treat Ebola virus. Shanghai Desano Biopharmaceuticals obtained an approval for a fixed dose combination of Dolutegravir, lamivudine and tenofovir disoproxil fumarate to treat HIV-1. Gilead Sciences received an approval for Veklury, the first medication to treat COVID-19.
There are two companies who received tentative approvals – 1. Laurus labs for a combination of Dolutegravir; emtricitabine; tenofovir alafenamide and 2. Teva Pharma for Micafungin sodium.
Mannitol is a commonly used excipient in pharmaceutical formulations. Chiesi received an approval for Bronchitol, which contains Mannitol as an active. Mannitol is able to attract water. When directed to the lungs, using a small dry powder inhaler device, mannitol draws water into the airways and moisturizes the mucus, making it easier for patients to expel the mucus. By increasing mucus clearance, Bronchitol can help improve lung function and quality of life for people with Cystic Fibrosis.
Endo Ventures worked with Nevakar Inc. to develop a ready-to-use Ephedrine injection formulation. The current formulations contain 50 mg/mL ephedrine, which are diluted prior to administration. The present formulation contains 5 mg/mL ephedrine (patent # 10,869,845).
Obesity due to POMC, PCSK1 or LEPR deficiency are ultra-rare diseases caused by variants in POMC, PCSK1 or LEPR genes that impair the MC4 receptor pathway. MC4 is a receptor pathway in the hypothalamus that is responsible for regulating hunger, energy expenditure and consequently body weight. People living with obesity due to POMC, PCSK1 or LEPR deficiency struggle with extreme, insatiable hunger beginning at a young age, resulting in early-onset, severe obesity. IMCIVREE as an MC4 receptor agonist, is designed to restore impaired MC4 receptor pathway activity arising due to genetic deficits upstream of the MC4 receptor.