Makena Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal
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.
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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.
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.
Company is not entitled to CDER's unredacted materials or predecisional drafts and emails on the proposed withdrawal of accelerated approval. However, presiding officer Celia Witten sets a 24 January deadline for CDER’s document production and requests the center re-examine what materials from a medical policy council meeting can be released.