Lawmakers and the public have been keeping a hawklike watch lately on companies that win new approvals for old meds. The latest to join that club? Allergan, which can expect to see its pricing strategy for newcomer Noctiva put under the lens.
Last week, Serenity Pharmaceuticals scored an FDA win for Noctiva (desmopressin acetate), the first agency-approved treatment for nocturnal polyuria—a condition that causes the overproduction of urine during the night. It’s a med that Allergan’s been partnered on since April 2010.
It’s also a version of a drug that’s been on the market since 1978 for a wide variety of uses, from central diabetes insipidus to hemophilia A. Ferring Pharmaceuticals sells an oral version and a nasal spray formula of desmopressin under the name DDAVP, though neither of those products is approved for nocturnal polyuria.
The Allergan/Serenity product is the latter, so Noctiva isn't an entirely new delivery system, either. And that means that if Allergan wants to slap a lofty price tag on the product, it could meet with some serious criticism.
For now, the Dublin drugmaker is staying mum on that front; a spokesman said in a statement that the company had “no comment on potential pricing.”
Other companies, though, have lately faced mounting pushback for shepherding old drugs down the regulatory pathway in exchange for new revenue streams. Just ask Marathon, whose Duchenne muscular dystrophy green light for corticosteroid deflazacort has lawmakers up in arms.
While Allergan’s next move has the potential to land it in a sticky situation—and make or break consumer confidence in CEO Brent Saunders’ social contract with patients—Ferring obviously wishes it were in the drugmaker’s shoes.
Ferring had itself been trying to land the first-ever nocturnal polyuria approval—positioning the treatment under the name Nocdurna—when an FDA advisory panel dealt the med a blow with a vote against approval. And Ferring, apparently, didn’t want Allergan and Serenity to have what it couldn’t: Late last year, it petitioned the FDA to “ensure that FDA treats the applications similarly and applies the same approval standards, in the same manner, to both applications.”