KV crows over Makena purity as FDA checks claim

Tuesday was a good day for beleaguered KV Pharma ($KV.A), known recently for its he-said/she-said lawsuits with a former CEO and its exorbitant price setting of preterm-birth preventer Makena after FDA approval in February. The drugmaker has submitted data to the FDA showing irregularities in the compounded treatment for preterm births--based on the same active ingredient as Makena--that had been used exclusively for the condition prior to Makena's approval.

In other words, Makena is safer. "As with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product," the agency said in a statement.

KV's stock nearly doubled, reports St. Louis Today.

KV has a knack for eliciting out-of-the-ordinary statements from the FDA. Last spring, the drugmaker won market exclusivity for Makena and set a price point of $1,500 per treatment--a 100x increase over the cost of the compounded version--driving medical and congressional outrage until the company made concessions. At the same time, KV wrote to pharmacies telling them that the FDA would take enforcement action if they continued to sell the compounded product.

The FDA "clarified" its position in a statement: "At this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient."

The agency must have some confidence in the data just submitted by K-V showing purity and potency inconsistencies in the compounded version. It's now conducting sampling and analysis of the compounded treatment and bulk API. "Although FDA has not validated or otherwise confirmed the analyses provided by K-V, FDA has carefully reviewed the data and will conduct an on-site review of the laboratory analyses," according to the agency statement.

- here's the FDA statement
- see the K-V release
- here's the St. Louis Today article
- and here's the Dow Jones take

Special Report: KV Pharma - Pharma manufacturing consent decrees