KV Pharmaceutical isn't making any friends with the $1,500-per-dose price tag on its new drug for preventing premature births. Just approved by the FDA last month, KV's Makena is a commercial form of the low-cost progesterone treatments used by women for years.
Those progesterone treatments, made by compounding pharmacies, weren't FDA approved. And the FDA has been on something of a crusade to sweep aside unapproved drugs. The medical community had supported KV's quest to win the FDA nod for Makena, the Associated Press reports, because the quality of treatment would be more consistent, and it would be easier to obtain.
Physicians hadn't expected Makena to cost so much, however. And now that Makena has the FDA's blessing, the pharmacies that formulated weekly progesterone shots for women at $10 to $20 each must stop doing so, the Los Angeles Times reports. And that's making doctors angry. Insurers aren't likely to be happy either, given they'll be reimbursing at a much higher rate for a similar treatment.
KV tells the LA Times that it's launching a patient assistance program to make sure all women who need the drug can get it. Now that it has FDA exclusivity, KV will certainly be the go-to source.