FDA advisors have recommended approval of Daiichi Sankyo’s proposed blood thinner to treat certain patients with atrial fibrillation, putting the Japanese drugmaker one step closer to entering a fierce competition to replace the decades-old treatment warfarin.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 last week to support approval of Daiichi Sankyo’s NDA for Savaysa (edoxaban) 60-mg dose to reduce the risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation (NVAF).

The advisors ignored requests from agency reviewers to limit the drug’s use to only patients with moderate kidney problems.

The committee reviewed results from a Phase III, randomized trial that compared Savaysa to warfarin in adult NVAF patients. The study found that Savaysa was more effective than warfarin in reducing stroke and embolic event risk, and caused fewer major bleeding events, Daiichi Sankyo said.

An FDA review of the data, however, found that patients with normal kidney functions didn’t receive a fully effective dose of Savaysa while patients with mild kidney impairment did much better.

Agency reviewers recommended patients with mild kidney problems take a smaller dose of the drug, but didn’t specify the amount. Conversely, patients with no kidney problems should take a higher dose than 60 mg, according to FDA briefing documents. The FDA also floated another option that retains the 60-mg dose but inserts labeling that intends to limit the use of Savaysa “to patients with impaired renal function.”

The drugmaker said it was confident the results of the study will support approval of the product in a 60-mg dose and a dose reduction to 30 mg in selected patients.

The FDA does not have to abide by its advisors’ recommendations, but it usually does.
Daiichi Sankyo said it is also pursuing an indication for Savaysa to treat venous thromboembolism, but that indication was not considered at the meeting. 

If the FDA approves Savaysa, it would face stiff competition in the race to replace warfarin, an effective treatment that requires regular monitoring and dose adjustments. There are three marketed products that have a similar indication: Boehringer Ingelheim’s Pradaxa (dabigatran), Pfizer and Bristol-Myers Squibb’s Eliquis (apixaban) and Janssen’s Xarelto (rivaroxaban).

Savaysa has a PDUFA goal date of Jan. 8, 2015. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.