CMC concerns lead to FDA rejection of Theratechnologies’ concentrated version of lipodystrophy drug for HIV patients

Ther­at­e­ch­nolo­gies was hand­ed a com­plete re­sponse let­ter by the FDA for the more con­cen­trat­ed ver­sion of its mar­ket­ed lipody­s­tro­phy drug for HIV pa­tients, Egrif­ta SV, be­cause of chem­istry, man­u­fac­tur­ing and con­trol is­sues.

The F8 for­mu­la­tion of tesamore­lin was re­ject­ed due to con­cerns over the prod­uct’s lyophilized and re­con­sti­tut­ed ver­sions, no­tably on its as­says, im­pu­ri­ties, mi­cro­bi­ol­o­gy and sta­bil­i­ty. The FDA al­so asked for fur­ther in­for­ma­tion on the risk that the F8 for­mu­la­tion could trig­ger an im­mune re­sponse, ac­cord­ing to a Wednes­day press re­lease.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.