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Second time lucky for Takeda’s obesity drug

FDA approves Contrave three years after initial rejection
FDA headquarters White Oak

Takeda's weight loss drug Contrave yesterday received approval from the US FDA, making it the third obesity treatment backed in the US in the past two years.

The approval comes three years after the FDA denied approval for Contrave, an extended release combination of naltrexone hydrochloride and bupropion hydrochloride, due to concerns about the drug's long-term cardiovascular safety.

The FDA has now relented on this view, but has requested that once the drug hits the market Takeda and its development partner Orexigen perform a cardiovascular outcomes trial to assess the risk of heart problems.

Several other post-marketing trials are also required, including two trials investigating the drug's use in paediatric patients and a trial to evaluate the interaction between Contrave and other drugs.

Contrave has also been hit with several safety restrictions. The drug should not be used in patients with uncontrolled blood pressure as the “clinical significance of the increases in blood pressure and heart rate observed with Contrave treatment is unclear”. Blood pressure and pulse must be measured prior to treatment and should be monitored at regular intervals.

It's not just the cardiovascular risk that the FDA is concerned by, and Contrave should not be used in patients who have seizure disorders.

Safety issues are not a new problem for obesity treatments. There was a major scandal in the 1990s when two drugs - fenfluramine and dexfenfluramine – were linked to heart valve problems, leading to their withdrawal and a 13-year drought for obesity treatments in the US.

This ended in 2013 with the launch of two new treatments: Eisai and Arena's Belviq (lorcaserin HCL) and Vivus' Qsymia (phentermine/topiramate).

However, these drugs have their own safety issues to consider (both companies are also conducting post-marketing cardiovascular safety studies) and their performance has not matched expectations.

Considering Contrave's extra limitations on use Takeda faces a hard task to make an impact on the weight loss market.

More competition is on the way too as Novo Nordisk is planning to market its diabetes treatment liraglutide in an obesity indication. The drug faces an FDA advisory committee today although a briefing document published earlier this week appeared to endorse the drug's use as a weight loss treatment.

Article by
Thomas Meek

11th September 2014

From: Sales, Regulatory



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