FDA OKs Sanofi’s Diabetes DrugBy
The US Food and Drug Administration has approved Sanofi’s Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with Type 2 diabetes.
Adlyxin is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.
Adlyxin will be available in a disposable pre-filled pen in a single dose of 20 micrograms. Patients will also receive a disposable pre-filled pen in a single dose of 10 micrograms that they should initiate once daily for 14 days. On Day 15, patients will increase dosage to 20 micrograms once daily.
Adlyxin is approved under the proprietary name, Lyxumia in more than 60 countries and marketed in over 40 countries. Commercial launches include most EU countries, Japan, Brazil, Mexico,and India. Adlyxin was in-licensed from Zealand Pharma A/S.