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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER