June Approval Outlook

Two drugs have PDUFA dates in June. Bremelanotide is a subcutaneous Injection being developed to treat hypoactive sexual desire disorder and celiprolol is a beta-blocker being developed to treat Ehlers-Danlos syndromes.
 
Bremelanotide from AMAG Pharmaceuticals has a PDUFA Date of Jun 23, 2019, after the FDA had delayed review by 3 months. The drug is a Melanocyte-stimulating hormone and administered as a subcutaneous injection.  Bremelanotide is being developed as a treatment of hypoactive sexual desire disorder (HSDD) in women.  AMAG reported increased desire and lowered distress compared to placebo in two phase III 24-week trials with more than 1,200 women with hypoactive sexual desire disorder. The most common adverse effects are nausea, flushing and headache. No interaction between bremelanotide and alcohol has been reported. We have 6 published studies for bremelanotide in our knowledgebase. Click here to subscribe and view all six studies. 
 
Celiprolol from Acer Therapeutics has a PDUFA Date of Jun 25, 2019. The drug is an oral Beta-blocker being developed as a treatment for Ehlers-Danlos syndromes. In a trial of 53 vascular Ehlers-Danlos syndrome patients, 20% of celiprolol treated patients experienced arterial rupture or dissection, after four-years, compared to 50% with placebo in a study conducted by Greater Paris University Hospitals.  Acer performed a retrospective analysis and verified the 2010 study results in 2017. The most common adverse effect reported with celiprolol is fatigue. We have 1 published study for celiprolol in our knowledgebase. Click here to subscribe and view the study.
 
Next week we will review May’s approvals. Click here to review previous weekly updates.
 
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