FDA greenlights first generics of blood thinner

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/wutwhanfoto)
(Image: Getty/wutwhanfoto)

Related tags: FDA approval, Food and drug administration, Mylan, Bristol-myers squibb, Pfizer

Mylan and Micro Labs receive US FDA approval for two generic versions of Pfizer and BMS’ Eliquis, marking the first generic approvals of direct oral anticoagulants.

Eliquis (apixaban) is an anticoagulant used for the treatment of blood clots and prevention of stroke in people with nonvalvular atrial fibrillation, marketed by Bristol-Myers Squibb and Pfizer.

Indications of the drug product also include the prevention and treatment of deep vein thrombosis, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery.

A blockbuster drug​, Eliquis brought BMS sales of over $5.9bn​ (€5.2bn) in the first three quarters of 2019. The approved generic versions are not projected to enter the market soon, as Eliquis is protected by patent until 2026.

During a Q3 earnings conference call, Giovanni Caforio, BMS’ CEO, commented that the company has reached settlements with over 20 other developers of apixaban, however “there are a small number of generic companies that are continuing to challenge the patent.”

Caforio added: “We feel very good about the fact that we have a strong patent estate for Eliquis,”​ while the company’s CFO, Charles Bancroft commented that the product sees continues growth and is expected to remain a ‘headwind’ among the company’s portfolio.

The two generic versions of apixaban gained approval by the US Food and Drug Administration (FDA) as direct oral blood thinners to prevent stroke and systemic embolism, with the regulatory body stating that this answers a ‘serious concern’, which affects up to 6.1 million US patients with atrial fibrillation.

By the end of 2019, the FDA marked a record by approving more than 1,000 generic drugs​, after having previously vowed to improve patients’ access to medicine and increase competition.

Although the US market experienced the largest generics penetration by volume during the past year, the region holds the lowest level of overall market value for generics, a recent report showed​.

Related topics: Markets & Regulations, Regulations

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