Will KV's 55% Makena price cut satisfy critics?

Answering a firestorm of criticism--as well as an unusual move by FDA--KV Pharmaceutical took an axe to the $1,500 price on its new prenatal drug Makena, cutting it back by 55 percent. The treatment, designed to prevent premature births, will now run $690 per weekly injection, and KV will offer additional rebates to make the drug more affordable to Medicaid programs.

KV had been facing an outcry ever since it first announced Makena's pricing. The newly approved drug is a commercialized version of a hormone injection that compounding pharmacists have been supplying to pregnant women for years, at $10 to $20 per shot. Patient groups, physician organizations, U.S. Senators and even the March of Dimes attacked the company, accusing it of price gouging.

"We understand the concerns that key stakeholders raised under our original pricing structure," CEO Greg Divis said in a statement. "We also recognize the current budget challenges facing state Medicaid programs and other payers."

KV's statement did not mention the FDA's unusual announcement Wednesday: That it would not go after compounding pharmacies that continued to supply their versions of the hormone injection, except in cases where quality was suspect. KV had sent pharmacies cease-and-desist letters, saying they'd violate FDA exclusivity rules if they kept selling their unapproved versions. But the agency's pledge reopened the door to those low-cost competitors.

It's unclear whether KV's price cut will be enough to woo women away from the compounded versions of the drug. In its statement, the company raised questions about the quality of compounded drugs, emphasizing the quality control and standardization of FDA-approved meds. And some organizations that have been criticizing KV actually supported its bid for Makena approval, welcoming the advent of an FDA-blessed version of the treatment.

- read the KV's release
- check out the Washington Post story
- get more from Reuters

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.