Another pharma company is facing supply constraints because of third-party contract manufacturing issues.
On Tuesday, Theratechnologies warned there is a risk its lipodystrophy drug for HIV, Egrifta SV, will be in short supply early next year due to an “unexpected” site shutdown at its third-party manufacturer. Earlier this week, Endpoints News reported that Coherus is also warning of supply constraints for its cancer drug due to issues at its contract manufacturer.
Following an FDA inspection, Theratechnologies’ unnamed contract manufacturer voluntarily shut down its facility for three months after the agency found issues at the facility. No issues were found with the direct manufacturing of Egrifta SV, Theratechnologies said.
Paul LévesqueThe contractor expects to begin production activities again by mid-October, with a batch of Egrifta SV scheduled to be made on Oct. 21. In the meantime, Theratechnologies is managing the inventory of the HIV drug to supply patients for the rest of the year and is “confident” no patients will be impacted in 2025, CEO Paul Lévesque said in a statement announcing the problem.
Theratechnologies said the FDA is also reviewing the timeline to start distributing Egrifta SV again. The agency requested the pharma company to submit a Prior Approval Supplement, detailing the changes the third-party manufacturer will make at the site.
Theratechnologies expects to lose $1.6 million in revenue in 2024 because of the shortfall. It pulled in $53.7 million in Egrifta SV sales last year.
Theratechnologies faced other regulatory hurdles with the FDA earlier this year, with another more concentrated formulation of Egrifta SV being rejected over manufacturing issues.