New Drugs Approved In September

fdaapproval oct04

The following are the new drugs approved in the month of September.


The FDA approved Gvoke, liquid glucagon, developed by Xeris Pharmaceuticals, Inc. (XERS) on September 10, 2019, for the treatment of severe hypoglycemia in diabetes patients of 2 years and older.

Hypoglycemia is characterized by dangerously low blood sugar levels.

Gvoke is the first glucagon product approved that can be administered via a pre-filled syringe (Gvoke PFS) or auto-injector-Gvoke HypoPen. Gvoke will be available in two doses- 0.5 mg/0.1 ml dose for pediatric patients and 1 mg/0.2 ml dose for adolescent and adult patients.

Xeris plans to make Gvoke pre-filled syringe available by late 2019 and the auto-injector in 2020. The U.S. potential annual sales opportunity for Gvoke HypoPen is estimated to be about $2.0 billion.

The company expects to submit the Marketing Authorization Application (MAA) of Gvoke to European Medicines Agency (EMA) by the end of this year.



The FDA approved Ibsrela, developed by Ardelyx, Inc. (ARDX), on September 12, 2019, for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

Ibsrela (tenapanor),a sodium-hydrogen exchanger, NHE3 comes as a 50 mg, twice daily oral pill. The company anticipates to strike a collaboration deal to support the launch of Ibsrela.

Ibsrela's key rival LINZESS, developed by Ironwood Pharma and Allergan, and indicated for IBS-C, had $761.2 million sales in the year 2018.


The FDA approved oral Semaglutide, developed by Novo Nordisk A/S (NVO), under brand name Rybelsus, on September 20, 2019, for the treatment of type 2 diabetes.

Semaglutide, which belongs to the class of glucagon-like peptide-1 receptor agonist (GLP-1 agonist), is already available in once-weekly injectable formulation under the brand name Ozempic.

Rybelsus is the first and only glucagon-like peptide-1 (GLP-1) in a pill, indicated for type-2 diabetes and it comes in 7 mg or 14 mg doses.

The company has priced the drug at $772.43 for a 30-day supply, or nearly $9,400 a year and will be available from Q4 2019.

Rival drug, Lilly's Trulicity (dulaglutide), had $3.199 billion sales in 2018. Novo's own Victoza, indicated for type 2 diabetes, that comes in an injectable form, brought in revenues of DKK24.33 billion in 2018.

The drug is under review by the regulatory authorities in many countries including Europe and Japan.

Novo's new drug application (NDA) for Rybelsus' additional indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease (CVD) is under review by the FDA with a decision expected in Q1 2020.



The FDA approved Jynneos vaccine, developed by Bavarian Nordic A/S (BAVA.CO), on September 24, 2019, for the prevention of smallpox and monkeypox in adults. This is the only FDA-approved vaccine available for the prevention of monkeypox disease.

Monkeypox is a rare disease caused by infection with monkeypox virus, characterized by symptoms similar to, but milder than, smallpox.

This vaccine is part of the Strategic National Stockpile (SNS), the nation's largest supply of potentially life-saving pharmaceuticals and medical supplies for use in public health emergencies.

The FDA granted Bavarian Nordic a Priority Review Voucher (PRV) under the Material Threat Medical Countermeasure PRV program. A PRV can be used to accelerate the FDA's review of a future human drug application and is also transferable. The company intends to sell the voucher to a third party.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT