After FDA snub, Akebia's oral anemia drug Vafseo nears EU nod

Watch out, GSK: Akebia Therapeutics isn't out of the anemia game just yet.

Last week, the company secured a positive opinion from a European Medicines Agency (EMA) committee for itsoral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, teeing up the drug for a likely European approval.

The Committee for Medicinal Products for Human Use (CHMP) has recommended Akebia’s oral HIF-PH inhibitor, Vafseo, to treat patients with anemia from chronic kidney disease who are on dialysis. The European Commission will now review the application and deliver a final verdict on the drug in about two months, Akebia said.

Many have tried, and failed, to treat patients with the condition who are not on dialysis. GSK recently tried for both patient populations with its own oral anemia drug, Jesduvroq, but ended up with an FDA approval for only the dialysis-dependent patient population.

Akebia also tried its luck at the FDA, but the company was turned away with a complete response letter last March. The company subsequently cut around half of its workforce.

The FDA’s concerns over the drug were clearly not shared by experts at the CHMP. In Europe, the committeee based its positive opinion on Akebia’s 7,500-patient development program, including phase 3 trials called INNO2VATE. In the INNO2VATE studies, Vafseo showed “non-inferiority” in helping patients stabilize hemoglobin levels compared to the standard treatment darbepoetin alfa.

Now, Akebia plans to “identify and secure” a partner to help bring the drug to patients in Europe. The company previously partnered with Otsuka on its FDA bid, but the two split last June.

Vafseo is already approved in Japan to treat chronic kidney disease anemia in both dialysis-dependent and non-dialysis-dependent adult patients.

GSK’s rival Jesduvroq has been under review at the EMA since last March.