One day after Theratechnologies revealed that the FDA's review of its drug application was taking longer than expected, the FDA has handed down a rejection.
The FDA issued a Complete Response Letter (CRL) to the company's filing for a higher-concentration formulation of tesamorelin for the reduction of excess abdominal fat in adult HIV patients with lipodystrophy, the company said Wednesday.
Tesamorelin is the only drug in the U.S. approved for this use, Theratechnologies pointed out. The company already markets a formulation that is half as concentrated as the proposed formulation.
That drug, Egrifta SV, is unaffected by the FDA's decision.
The FDA's rejection letter "largely" centers on issues related to chemistry, manufacturing and controls (CMC), the company said in its release. The agency also seeks information to better "understand the potential impact of the proposed formulation on immunogenicity risk."
Theratechnologies plans to respond to the agency and will continue to pursue approval for the new formulation.
“While we are disappointed to receive a Complete Response Letter from the FDA for the F8 formulation of tesamorelin containing questions that were not raised during the review process, we plan to address these new comments as swiftly as possible," the company's chief medical officer, Christian Marsolais, Ph.D., said in a statement.
The new formulation would enable a smaller volume of administration and allow for a new multiple-dose vial that is reconstituted just once per week, the company said when it submitted the filing in September.
While the FDA was busy throughout 2023 issuing dozens of new drug approvals, this is at least the fourth manufacturing-related rejection in the span of about a month. Since mid-December, FDA has also spurned filings from Zealand, Astellas, and Satsuma over manufacturing-related concerns.