Makena Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal
Executive Summary
Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.
You may also be interested in...
US FDA Still Hasn’t Decided Who Will Be Final Arbiter On Approval Status For Covis’ Makena
With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior leadership.
Makena Accelerated Approval Withdrawal Hearing Should Be In-Person, Covis Tells US FDA
Covis cites challenges of conducting virtual meetings but leaves door open to hybrid approach. CDER wants advisory committee vote on feasibility of timely conducting new adequate, well-controlled trial, while Covis seeks vote on whether withdrawal is appropriate given absence of another approved drug for preventing preterm birth.
US Accelerated Approval: As Makena Withdrawal Hearing Looms, A Look Back At The Avastin Experience
With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.