Ranbaxy SA defers launch of Ranbute (Sibutramine)
Ranbaxy SA has decided not to launch Ranbute, their generic sibutramine, this week despite having received MCC registration in the latter half of 2009.
The decision was made after the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) announced last week that they recommend the suspension of marketing weight-loss products containing sibutramine, due its possible association with an increased risk in cardiovascular events, compared with placebo.
The recommendation from the CHMP came after reviewing the safety data from the SCOUT trail. The Sibutramine Cardiovascular Outcome Trial (SCOUT) was designed to determine whether weight management in cardiovascular high-risk overweight and obese patients could impact upon cardiovascular endpoints. The results indicated serious risks, such as non-fatal heart attacks and strokes, in patients taking Sibutramine, compared with those receiving placebo.
Even though Ranbaxy's has to date invested substantial amounts in the development, “The safety of patients is non-negotiable”, a Ranbaxy spokesperson said.
Products that will be affected by the CHMP's recommendation include Abbott's Reductil, Aspen's Ectiva and Cipla's Ciplatrim. The committee's recommendation is that doctors should discontinue prescribing Sibutramine and that patients already using the products should consult with their physician "to discuss alternative measures to lose weight."
Available study data also demonstrated that weight loss with Sibutramine was "modest and may not be maintained after stopping," the CHMP explained, concluding that the risks of the drug as a weight-loss therapy did not outweigh its risks. The recommendation has been forwarded to the European Commission for a decision.
