Daiichi-Sankyo blood drug gets FDA nod
pharmafile | January 12, 2015 | News story | Sales and Marketing | BMS, Daiichi Sankyo, Daiichi-Sankyo, FDA, Pfizer, Pradaxa, atrial fibrillation, blood, savaysa
The US Food and Drug Administration has shown Daiichi-Sankyo’s anti-clotting drug Savaysa the green light to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation (AF).
Approved more than three years after making its debut in Japan, the treatment now becomes the fourth novel oral anticoagulant (NOAC) to enter the US market.
The firm and its drug now join a crowded market sitting alongside the likes of Boehringer Ingelheim, Johnson & Johnson/Bayer, plus Bristol-Myers Squibb/Pfizer who make up the NOAC bazaar with their own anti-clogging treatments.
Norman Stockbridge who is the director of the Division of Cardiovascular and Renal Products at the FDA, says: “It is important to have a variety of these types of drugs available as options for patients.”
Savaysa (edoxaban) has also been approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug.
The clinical trial for AF consisted of 21,105 participants, it compared two dose levels of Savaysa with the anti-clotting drug warfarin for their effects on rates of stroke and dangerous blood clots (systemic emboli).
The results showed that Savaysa equalled warfarin for the reduction in the risk of stroke. During the trials the drug also caused significantly less major bleeding compared to warfarin.
“In patients with AF, anti-clotting drugs lower the risk of stroke by helping to prevent blood clots from forming in the heart,” adds Stockbridge.
AF is one of the most common types of abnormal heart rhythm disturbance, it occurs when the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form. Patients with the condition experience an abnormal, irregular and rapid heartbeat and the illness affects up to 800,000 people in the UK.
Savayso may have a hard time competing in such an established marketplace alongside drugs that have been ready and available to patients for several years.
A notable competitor for Daiichi will be Boehringer’s controversial Pradaxa (dabigatran), a treatment that has been a strong growth driver for the firm, bringing in $1.5 billion in 2014.
Tom Robinson
Related Content
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
FDA grants ODD to Candel Therapeutics’ pancreatic cancer treatment
Candel Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan …
