Sanofi has withdrawn and refiled its pre-merger notification and report form in connection with its pending acquisition of Provention Bio in order to provide the Federal Trade Commission with additional time for review.

The French drugmaker announced the $2.9 billion deal last month. Key to the transaction is Provention’s first-in-class type 1 diabetes, Tzield, approved last November. 

Sanofi initially filed the notification form on March 24. The refiling will extend the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act to April 25, 2023, giving the FTC more time.

Concerned about the increased consolidation in the biopharma space, back in 2021 the FTC announced a new working group, comprised of antitrust enforcers from around the globe, focused on taking “an aggressive approach to tackling anticompetitive pharmaceutical mergers.” The initiative vowed to evaluate pharma mergers in light of concerns about anticompetitive behavior and drug pricing.

Rare disease drugmaker Horizon Therapeutics and Amgen ran into issues earlier this year, revealing that the FTC had requested additional information and documentary materials concerning the proposed $27.8 billion mega-deal. 

As for the Sanofi deal, despite the delay, the drugmaker says the acquisition is still expected to close in the second quarter of 2023.