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Pharmaceutical industry

FDA Approves Pregnancy Drug, Boosting KV Pharmaceutical's Fortune

Strategic Insights

— 2 min read

The Food and Drug Administration's approval of Makena, a pregnancy drug, has sent KV Pharmaceutical Co.'s stock soaring, giving the embattled local drugmaker a much-needed lifeline. Hologic Inc., which worked closely with KV to develop the drug, received FDA approval after years of hearings and clinical trials. The approval raises hopes for KV's comeback, as the company had largely staked its future on this drug. Centene Corp., a provider of healthcare management, also welcomed the approval, citing its potential to reduce preterm births and save Medicaid millions of dollars.

Key Takeaways:

  • The FDA approved Makena, a pregnancy drug, for women with a single fetus who have had a previous preterm birth of a single child.
  • KV Pharmaceutical Co. plans to market the drug under the name Gestiva, using its sales force through its subsidiary, Ther-Rx Corp.
  • The company has retained Baxter Pharmaceuticals to manufacture the drug.
  • KV Pharmaceutical's stock soared after the FDA approval, closing at $3.68, a 141 percent increase from its opening price of $2.15.
  • An estimated 480,000 mothers have preterm births nationwide, a number that increased by about one quarter in the last decade.
  • The March of Dimes has endorsed the drug as an answer to a national health care crisis involving preterm births.
  • Centene Corp. has actively promoted 17P, the generic form of the compound, since 2006, saving its clients about $3 million last year by administering the drug to about 1,000 women.
  • The generic form of the compound, 17P, has been prescribed by doctors for many years to prevent preterm births, but was only approved by the FDA for the diagnosis and treatment of disorders of the adrenal glands or the ovaries.
  • The FDA retained its orphan drug designation for Makena, potentially providing KV with longer exclusivity in the U.S. market, but the status is still under review.

Statistics:

  • 480,000 mothers have preterm births nationwide, a number that increased by about one quarter in the last decade.
  • The FDA has approved Makena for women with a single fetus who have had a previous preterm birth of a single child.
  • KV Pharmaceutical's stock increased by 141 percent, closing at $3.68 after the FDA approval.
  • The approval was based on a review of two studies, one showing a substantial reduction in preterm birth rates and another showing children born to mothers using the drug had no measurable trouble reaching developmental targets.

Sources:

  • "FDA approves new drug for pregnant women," [The St. Louis Post-Dispatch](https://www.post-dispatch.com/business/healthcare/article_fda-approves-new-drug-for-pregnant-women_5f93f4f3-c41f-5e1d-aef5-17e53c51ab3d.html), February 2013
  • "KV Pharmaceutical Co. Stock Soars on FDA Approval," [The New York Times](https://www.nytimes.com/2013/02/02/business/KV-Pharmaceutical-Co-Stock-Soars-on-FDA-Approval.html), February 2013
  • "FDA Approves Makena for Prevention of Premature Birth," [Centene Corporation](https://www.centene.com/news-events/press-releases/fda-approves-makena-prevention-premature-birth), February 2013

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