First approved in 2011 under the fast-track approval pathway to reduce the risk of premature births, Covis Pharma’s Makena failed its confirmatory study, not showing the drug works, but the company still refused to withdraw it from the market.
Since October 5, 2020, when CDER first proposed to withdraw Makena’s expedited approval, Covis has provided additional information and exchanged legalese with the FDA on multiple occasions about how this withdrawal hearing should unfold.
CBER Deputy Director Celia Witten, who is presiding over the hearing, previously told Covis that the design of any future confirmation lawsuits is not a matter for this hearing and takedown process.
Even still, the final voting question for the 2.5-day panel in October will ask, “Should the FDA allow MAKENA to remain on the market while a proper confirmatory study is designed and conducted?”
In addition, the other two voting questions will be:
- Do the results of trial 003 verify the clinical benefit of MAKENA on neonatal morbidity and mortality due to complications of preterm birth?
- Does the available evidence demonstrate that MAKENA is effective for its approved indication of reducing the risk of preterm birth in women with a single pregnancy with a history of single spontaneous preterm birth?
Other discussion questions, according to a Federal Register notice published today, will discuss Makena’s benefit-risk profile and whether it supports keeping the product on the market, and what types of studies could provide confirmatory evidence for verify the clinical benefit of Makena on newborn morbidity and mortality due to complications of preterm delivery.
Covis previously said in a statement that it urged the FDA to allow the company to conduct additional research to fully explore Makena’s effectiveness for indicated patients, “and looks forward to presenting proposed study options when of the October hearing”.
The company said it was developing:
Options that enhance the previous sponsor’s proposal for additional studies. Specifically, Covis is exploring two alternative options: (1) conduct a prospective historical control study, in accordance with FDA guidelines, and/or (2) conduct a randomized clinical trial (RCT) based on analysis of datasets retrospectives in order to identify relevant subgroups for study.
The 2.5-day hearing will be held virtually from October 17-19, 2022, beginning at 8 a.m. and ending at 4 p.m. on the first two days and 12:30 p.m. on the third day.
In a show of fairness, the agency previously said the hearing will allow both Covis and CDER to make two-hour presentations each, and both sides will receive a full hour to ask questions after the opposing party will have made its presentation. An additional four hours will be set aside for public comment, allowing generic makers of Makena to have their say as well.
FDA Chairman Witten also subsequently granted Covis’ requests to submit additional data and information that was not included in its December 4, 2020 submission “and may do so again based on ‘a demonstration of good cause’, on Tuesday. notice said.