“While we stand by Makena’s favorable risk-benefit profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Covis Chief Innovation Officer Dr. Raghav Chari said in a news release. . It also voted that a postmarket trial didn’t show any benefit to babies and that the evidence didn’t show that Makena reduced the risk of preterm birth in women who had had one before.
Covis says that soon after the committee hearing, it outlined a plan for withdrawal that included a wind-down period allowing patients to finish the 21-week course of treatment. However, the FDA’s Center for Drug Evaluation and Research rejected the plan. “Covis remains prepared to work cooperatively with the Agency to accomplish an orderly wind-down and withdrawal of Makena and its generics from the market,” the company said Monday in a letter to FDA Commissioner Dr.
I’ve been on Makena for 12 weeks and my OB told me today it was being pulled. It’s hard thinking I had an answer for a possible preterm birth and now knowing there is nothing I can do and the painful shots weren’t really doing anything… on top of being $1000 a shot.
Now do the Covid vaccine.
The vaccine has also proven not to work against c19 but your not pulling that. Wonder why?
Now if they would have only done that with the Covid vaccines. Think of the lives they would have saved.
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Fonte: WSJ - 🏆 98. / 63 Consulte Mais informação »