EU panel backs approval of generic version of oral heart drug

Regulatory authorities in the European Union (EU) have recommended approval of Tafamidis Accord, a generic version of Vyndaqel (tafamidis), an approved treatment for adults with hereditary transthyretin amyloid cardiomyopathy (hATTR-CM).

A generic medicine has the same active ingredient, strength, and route of delivery as its reference brand-name drug, as well as equivalent safety, efficacy, and movement into, through, and out of the body. However, generics are typically cheaper, and, by introducing market competition, can help drive down drug prices.

The Committee for Medicinal Products for Human Use, which reviews safety and efficacy data for experimental therapies being considered for EU approval, gave a positive opinion for Tafamidis Accord’s 61 mg soft gel capsules.

Developer Adalvo also said the generic has received approval under the EU’s decentralized procedure, a regulatory mechanism that allows some therapies to be simultaneously approved in multiple member states.

Pfizer holds patents on name-brand Vyndaqel — sold as Vyndamax in the U.S. — that prevent generic competition in most European countries until November. Separate market exclusivity for the hATTR-CM indication protects the brand from generic competition until February 2030. Adalvo said it and its commercial partners will be ready to launch its generic “upon expiry of applicable exclusivities and [intellectual property] rights.”

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“Tafamidis is a clear example of Adalvo’s growing strength in complex rare disease therapies, “Anil Okay, CEO of Adalvo, said in a company press release. “Securing approval on an asset of this commercial and clinical standing takes deep technical capability and precise regulatory execution. Achieving it through two parallel European routes speaks to the strength of both our dossier and our partnerships. I’m proud of the team, and proud that Adalvo continues to give partners access to differentiated therapies in the areas where patients need them most.”

hATTR-CM is caused by mutations in the TTR gene, which result in the production of a faulty transthyretin (TTR) protein that is prone to form toxic clumps in the heart. ATTR-CM symptoms are typically associated with heart failure.

Tafamidis, the active ingredient in both Vyndaqel (61 mg) and the generic Tafamidis Accord, works to stabilize the TTR protein so it will not form disease-driving clumps. In clinical trials, Vyndaqel was shown to significantly reduce rates of death and cardiovascular-related hospitalizations in people with hereditary and non-hereditary forms of ATTR-CM, as well as to slow declines in exercise capacity and life quality.

In the EU, Vyndaqel (61 mg) is currently the only approved once-daily, single-capsule oral treatment for hATTR-CM. In the U.S., Vyndamax is approved to treat adults with hereditary and non-hereditary forms of ATTR-CM.

According to Adalvo, global sales of tafamidis totaled more than $6 billion in 2025, a 17% increase over the previous year. The company said the growth was largely driven by better awareness of ATTR-CM, making tafamidis “one of the world’s most commercially significant rare disease therapies.”