Lilly’s diabetes drug matches Victoza
pharmafile | February 26, 2014 | News story | Research and Development, Sales and Marketing | EMA, FDA, Victoza, dulaglutide, lilly
Eli Lilly’s once-weekly diabetes candidate dulaglutide has matched Novo Nordisk’s established once-daily Victoza (liraglutide) when it comes to lowering blood sugar.
The head-to-head Phase III AWARD-6 study proved the investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist’s non-inferiority to Victoza.
It is a significant finding, since ease and frequency of use is a key factor in how successfully patients adhere to their drug regime and a once-weekly dose will be attractive.
Dulaglutide 1.5 mg achieved the primary endpoint of non-inferiority to Victoza 1.8 mg, as measured by the reduction of haemoglobin A1c (HbA1c) from baseline at 26 weeks.
“Dulaglutide is the only GLP-1 agonist to show non-inferiority against liraglutide’s highest- approved dose in a Phase III trial,” said Enrique Conterno, president of Lilly Diabetes.
The drug is one of at least three new medicines Lilly plans to launch this year: there is one other in diabetes – empagliflozin, which is co-marketed with Boehringer Ingelheim – and ramucirumab in advanced gastric cancer.
Lilly has had high hopes for dulaglutide since it beat three close rivals – Bristol-Myers Squibb’s Byetta, generic metformin and Merck’s blockbuster pill Januvia – in reducing blood sugar in a trial last year.
The new findings are significant because this had already showed the drug’s potential as a blockbuster – and Victoza is dulaglutide’s nearest probable competitor.
Dulaglutide has already been submitted to regulators including the US Food and Drug Administration and the European Medicines Agency.
All five AWARD trials (1-5) before this one also achieved their primary endpoint in reduction of HbA1c at the 1.5 mg dose against placebo and active comparators.
Lilly says it will present detailed data from AWARD-6 plus AWARD-2, which pitched dulaglutide against Sanofi’s multi-billion dollar seller Lantus (insulin glargine), at scientific meetings later this year.
The two companies are currently embroiled in a US lawsuit after the French manufacturer alleged that Lilly has infringed four patents on Lantus with another pipeline product.
The market in this therapy area is huge, since around 371 million people worldwide have diabetes, up to 95% of whom have type 2.
Lilly needs a lift since the patents on two big-sellers, Cymbalta and Evista, have either gone or are about to, resulting in a “substantial decline in revenue and earnings in 2014”, the firm has admitted.
Adam Hill
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