FDA Roundup: Nasal Spray for Gastroparesis in Women


This week, the FDA received an application for a metoclopramide nasal spray and a receptor agonist for hypoactive sexual desire disorder, approved baricitinib on its second try, and granted Priority Review to emicizumab for hemophilia A.

Hi, I’m Cecilia, and welcome to MD Magazine’s weekly FDA Roundup. Let’s see what the agency has been up to this week.

A New Drug Application was submitted to the FDA for a nasal spray product that could relieve symptoms in adult women with either acute or recurrent gastroparesis.

The metoclopramide nasal spray, from the specialty pharmaceutical company Evoke Pharma, had been successfully submitted for the FDA’s consideration last week, with expectation that a substantive review will be made available in early August.

Another application accepted was for bremelanotide, a first-in-class melanocortin 4 receptor agonist designed for treatment of hypoactive sexual desire disorder in premenopausal women. In the acceptance letter, the FDA stated that it’s currently planning to hold an advisory committee meeting discussing the application.

In a turn of events for Eli Lilly’s baricitinib, the FDA approved the treatment after rejecting it last year. The drug is approved for treatment in adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies.

Lastly, the FDA accepted a supplemental biologics application and granted Priority Review to emicizumab for adults and children with hemophilia A without factor 8 inhibitors. Emicizumab is an antibody that, in place of the missing factor 8, joins factor 9a and factor 10, activating the natural coagulation process in people with hemophilia A who lack sufficient factor 8.

Given the Priority Review, the company expects a decision from the FDA regarding this application in October 2018.

For these stories and more, visit us at MDMag.com. This has been Cecilia with your FDA Roundup, thank you for watching.

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