Novo Nordisk, Sanofi, and J&J Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Sanofi, Novo Nordisk, and J&J.

Editor’s Note: Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, September 27, 2017 to Tuesday, October 3, 2017.

FDA OKs Novo Nordisk’s Fast-Acting Insulin
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Fiasp (insulin aspart injection) 100 units/mL, as a mealtime insulin indicated to improve glycemic control in adults with Type I and Type II diabetes. The drug is a potential competitor to Eli Lilly and Company’s insulin, Humalog (insulin lispro injection), which was Lilly’s top-selling drug in 2016 with global sales of $2.8 billion.

Fiasp is a new formulation of NovoLog, Novo Nordisk’s original insulan aspart, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes, according to Novo Nordisk. Fiasp will be available in a pre-filled delivery device FlexTouch pen and a 10-mL vial.

Source: Novo Nordisk

EC OKs Sanofi’s, Regeneron’s Dermatitis Drug
The European Commission has approved Dupixent (dupilumab), from Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, for treating adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent is slated as a potential blockbuster drug by some analysts.

Dupixent was approved by the US Food and Drug Administration in March 2017 for treating adults with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies.

Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13. Dupixent comes in a pre-filled syringe and can be self-administered by a patient as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids.

A recent analysis by Clarivate Analytics projects 2021 sales of the drug at $2.8 billion.

Source: Sanofi and Regeneron

EC OKs J&J’s HIV Combo Drug
The European Commission has approved Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), from Janssen Pharmaceutica, one of the Janssen Pharmaceutical companies of Johnson & Johnson, for treating human immunodeficiency virus type 1 (HIV-1).

Symtuza is a once-daily darunavir-based single-tablet regimen (STR), for treating HIV in adults and adolescents aged 12 years and older with body weight of at least 40 kg. Cobicistat, emtricitabine, and tenofovir alafenamide are from Gilead Sciences, and darunavir is from Janssen. Darunavir was approved as a single-agent for treating HIV in November 2012.

Source: Janssen


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