Pancreatitis concerns take shine off Victoza approval
pharmafile | January 28, 2010 | News story | Sales and Marketing | GLP-1, Novo Nordisk, Victoza
The FDA has approved Novo Nordisk’s Victoza a new once-daily injection for patients with type II diabetes.
The drug will be used in patients struggling to control blood glucose on existing oral treatments, and could help them delay the need for insulin injections.
It is to be used after metformin or sulphonylurea, and can be used alone or in combination with one of the established diabetes drugs if they fail to control blood glucose on their own.
Victoza (liraglutide) will compete with Byetta (exenatide), the rival treatment from Lilly and Amylin. Like Byetta, it works by stimulate the release of insulin when blood sugar levels are high.
Data from a head-to-head study between the drugs seems to give Victoza a clear lead over its rival. A study published last year found Victoza achieved greater control of blood glucose levels and had fewer tolerability issues.
Novo Nordisk believes the drug could earn peak sales in excess of $1billion, but it must first overcome doubts about its safety.
Victoza safety monitoring
Victoza has been subject to delays by regulators, after a FDA advisory panel raised several doubts about adverse events.
Pre-clinical trials showed an increase in thyroid cancers in rodents, although the test subjects were given eight times the amount that will be administered to human patients.
The FDA have several post-marketing requirements, the first is for Novo to conduct a five-year epidemiological study to evaluate thyroid and other cancer risks as well as evaluate the risk for hypoglycemia, pancreatitis and allergic reactions (such as hives).
From this precaution, the FDA is recommending that those with or at higher risk of medullary thyroid cancer or pancreatitis do not take Victoza.
The other requirement is to evaluate Victorza’s cardiovascular safety in a higher risk population, as clinical trials to date have only tested reactions on low-risk patients.
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