It’s been almost 10 months since the FDA granted Covis Pharma a hearing to review its controversial preterm birth drug Makena, which won an accelerated approval but failed its confirmatory trial, and still the company and FDA are wrangling over the details of that hearing.
In a letter dated Thursday, Covis lawyers from Sidley are now objecting to the hearing, including a publication that suggests a potential link between Makena and cancer in the offspring.
The study in question, published in the American Journal of Obstetrics and Gynecology, reviewed the cancer risk of thousands of babies born in the Bay Area to mothers given 17-α hydroxyprogesterone caproate, with the researchers concluding that caution of use in early pregnancy is warranted, given the possible link with cancer in the offspring.
But Sidley submitted comments from an outside expert witness and stats consultant, Anita Das, who noted that Makena is indicated for the prevention of recurrent preterm birth and only for administration starting at 16 weeks of gestation, whereas the study showed “a significant increased risk of any cancer” only when 17-α hydroxyprogesterone caproate, known then as Delalutin, was administered in the first trimester or up to about 12 weeks.
Sidley lawyer and former FDA chief counsel Rebecca Wood also wrote to FDA that the study is “neither sufficiently reliable to be considered nor relevant to the safety and efficacy of Makena,” and “it would be error, both legally and as a matter of sound public health policy, for FDA to include it in the hearing record or otherwise to consider it in connection with the proposed withdrawal of accelerated approval for Makena.”
She also explained how the American College of Obstetricians and Gynecologists has concluded that this article “does not change the risk-benefit profile of Makena,” saying that due to limitations in the design, the study’s findings are not conclusive and should not influence practice.
But other doctors aren’t so sure that such evidence should be dismissed by FDA ahead of the hearing. And the FDA has yet to announce its decision on what it will do.
Adam Urato, an an obstetrician-gynecologist in Framingham, MA, told Endpoints News the request from Sidley is “outrageous,” adding:
Sidley/Covis wants FDA to ignore the Murphy study showing a link between synthetic progesterone during pregnancy and cancer in the offspring. This is a major issue. We don’t know the long-term effects of injecting women with Makena. It absolutely could potentially cause cancer in the exposed offspring. That’s certainly a possibility. This is a very important issue to be discussed and here we have Covis arguing that FDA must not even consider it or include it in the hearing record. This is a scientific paper that was peer reviewed and published in a leading OB/GYN journal (the official journal of the Society of Maternal Fetal Medicine.) FDA must say no to this.
Regardless of the inclusion of this study, the FDA and Covis Pharma will duel it out during a two-and-a-half-day virtual hearing set for next September or October, according to a letter from Celia Witten, FDA’s director of the Office of Cellular, Tissue and Gene Therapy, who’s presiding over the hearing.
FDA plots multi-day hearing to review 'dangling' accelerated approval that drugmaker refuses to pull
The hearing will allow for both Covis and FDA’s Center for Drug Evaluation and Research to each make two-hour presentations, and both CDER and Covis will be given a full hour to ask questions after the opposing side makes its presentation. An additional four hours will be set aside for public comments.
“I must afford CDER and Covis an opportunity to ask questions after presentations by the public and reserve time for the advisory committee members and me to do so, as well,” Witten wrote to attorneys from both CDER and Covis. The third day (a half day) will allow for closing statements from both sides.
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