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What Belviq Labeling Means For Other Obesity Drug Sponsors

 
• By Cathy Dombrowski

Arena’s Belviq is the first obesity drug approval in over a decade, but it won’t be the only one for long. A look at the FDA-approved labeling for lorcaserin offers a preview of how the agency could handle similar issues for Qnexa and, further down the line, Contrave.  

FDA’s approval of Arena Pharmaceuticals Inc.’s Belviq (lorcaserin) shows that the scales have tipped in the agency’s consideration of the risk-benefit ratio for obesity drugs, and bodes well for Vivus Inc.’s pending Qnexa. How FDA has handled many of the common issues for obesity therapeutics in lorcaserin’s label offers a preview of what could be in store for the other drugs.

Arena’s novel serotonin receptor agonist cleared FDA June 27 as an adjunct to diet and exercise for chronic weight management...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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US Return Of GSK’s Blenrep Threatened By Ocular Toxicity, Dosage Optimization Questions

 
• By Sue Sutter

The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
• By Derrick Gingery, Sue Sutter, and Sarah Karlin-Smith

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

Spain’s Medicines Shortages Plan Clears Administrative Hurdles For Essential Medicine Manufacturers

 
• By Francesca Bruce

A new plan to tackle medicine shortages proposes to develop a set of incentives for companies to manufacture essential medicines in Spain.