Teva, Novo Nordisk, and Sanofi Lead Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Teva, Novo Nordisk, and Sanofi.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, December 6, 2017 to Tuesday, December 12, 2017.
Teva Launches Generic of Pfizer’s Viagra in the US
Teva Pharmaceutical Industries has launched in the US a generic version of Pfizer’s Viagra (sildenafil citrate), a drug to treat erectile dysfunction drug. Pfizer recorded direct product sales of more than $1 billion for Viagra (US and Canada) in 2016.
The launch follows an agreement reached by Pfizer and Teva in December 2013 relating to Pfizer’s patent covering the use of Viagra to treat erectile dysfunction (sildenafil citrate 25, 50, and 100 mg tablets), which expires in April 2020 (including pediatric exclusivity). As a result of the settlement, Teva was allowed to launch a generic version of Viagra in the US on December 11, 2017, or earlier under certain circumstances. Teva agreed to pay Pfizer a royalty for a license to produce its generic version.
Source: Teva Pharmaceutical Industries
FDA OKs Novo Nordisk’s Diabetes Drug Ozempic
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s new drug application for Ozempic (semaglutide) injection as a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes.
Ozempic is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals. Ozempic is approved for use in two therapeutic doses, 0.5 mg and 1 mg, and will be launched in the Ozempic pre-filled pen.
Novo Nordisk expects to launch Ozempic in the US in the first quarter of 2018.
Semaglutide is currently under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
Source: Novo Nordisk
FDA Approves Sanofi’s Follow-on Insulin Injection of Lilly’s Humalog
The US Food and Drug Administration (FDA) has approved Sanofi’s Admelog, a follow-on insulin lispro similar to Eli Lilly and Company’s Humalog (insulin lispro injection), which had 2016 global sales of $2.8 billion.
Lilly’s Humalog is another insulin lispro 100 units/mL currently approved in the US. Admelog will be available in both vials and the SoloStar pen, Sanofi’s disposable insulin pen platform.
Admelog was also granted marketing authorization as a biosimilar, under the proprietary name, Insulin Lispro Sanofi, by the European Commission in July 2017.
FDA OKs New Use for GSK’s Respiratory Drug Nucala
The US Food and Drug Administration has approved a new use of GlaxoSmithKline’s respiratory drug, Nucala (mepolizumab), to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), an autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body.
The FDA says this new indication provides the first FDA-approved therapy specifically to treat EGPA.
The FDA granted this application priority review and orphan-drug designation. Nucala was previously approved in 2015 to treat patients age 12 years and older with a specific subgroup of asthma (severe asthma with an eosinophilic phenotype) despite receiving their current asthma medicines. Nucala is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) produced by recombinant DNA technology in Chinese hamster ovary cells.
Nucala is administered once every four weeks by subcutaneous injection by a health care professional into the upper arm, thigh, or abdomen.