BioPharm Insight’s™ New Obesity Report Highlights EMA Approval Difficulty and New Developments

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EMA’s cynicism toward anti-obesity drugs will hinder Belviq and Qsymia EU approvals

This summer brought two new anti-obesity drugs to the market. On June 27th, the FDA approved Belviq (lorcaserin), a 5-HT2C receptor agonist, from Arena Pharmaceuticals, the first prescription weight-loss drug to hit the US market in more than a decade. Arena submitted a Marketing Authorization Application (MAA) for Belviq to the European Medicines Agency (EMA) in 2012. The second anti-obesity drug FDA approved this year was Vivus’ Qsymia on July 18th. The company filed an MAA in December 2010. The EMA’s Committee for Medicinal Products for Human Use is unlikely to recommend approval, Vivus said.

Qsymia and Belviq are unlikely to see EU approval for several years, according to the experts interviewed by BioPharm Insight. European regulators will wait for US post-marketing data or results from cardiovascular (CV) outcomes trials. Additionally, the EMA has not faced the same degree of organized political and patient advocacy pressure as the FDA. The EMA still perceives obesity as a psychobehavioral disorder rather than a risk factor for diabetes and hypertension. While Belviq’s safety profile is superior to Qsymia, its efficacy is likely to be scrutinized considering the EMA’s cynicism toward the role of anti-obesity drugs.

Another anti-obesity drug on the path to approval is Orexigen Therapeutics’ Contrave, which received a complete response letter in January 2011. The FDA expressed concern about the drug’s CV safety profile when used long-term in obese and overweight patients. The agency requested the company to conduct a study to assess the occurrence of major adverse cardiovascular events (MACE). Orexigen has thus initiated a Phase III study called LIGHT. NDA resubmission is expected in 2Q/3Q13.

Still in development, Orexigen’s other anti-obesity candidate, which is in Phase II, has completed enrollment in its second Phase IIb trial, a 24-week study in healthy, nondiabetic, obese people. On September 22nd, Zafgen, a Massachusetts-based private company, announced data from two Phase Ib studies of beloranib, a methionine aminopeptidase 2 (MetAP2) inhibitor. It showed rapid weight loss, reductions in body fat and improvements in cardiovascular disease risk markers in severely obese women.

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About BioPharm Insight
BioPharm Insight is the definitive guide to the global biopharma community. BioPharm Insight provides clients with an information edge by combining the most comprehensive real-time database of companies, drugs, contacts, M&A and licensing deals, forecasts and clinical trial data with proprietary forward-looking intelligence uncovered by an independent team of investigative journalists months or even years before it breaks in mainstream media. To learn more, visit http://www.biopharminsight.com.

About Infinata, Inc.
Featuring a comprehensive BioPharm Solutions Suite, unique Wealth Prospecting tools and innovative Custom Data Services, Infinata provides personalized technology solutions to turn information into insight. Infinata is a part of Mergermarket, a Financial Times Group company, and a division of Pearson plc. To learn more, visit http://www.infinata.com.

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Kristopher Sarajian
Infinata
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