Pfizer to Discontinue Low-Dose Vyndaqel in US, Simplifying ATTR-CM Treatment Options

Pfizer has announced plans to discontinue Vyndaqel, the low-dose version of its tafamidis franchise for transthyretin amyloid cardiomyopathy (ATTR-CM), in the United States by the end of 2025. This strategic move aims to streamline treatment options and enhance patient-centered care for those living with the rare heart disease.

Transition to Single-Pill Vyndamax

The pharmaceutical giant's decision will leave Vyndamax, the high-dose formulation, as the sole tafamidis brand available in the US market. Vyndamax offers the same active ingredient and clinical benefits as Vyndaqel but in a more convenient single 61-mg capsule taken once daily, compared to Vyndaqel's regimen of four 20-mg capsules.

A Pfizer spokesperson confirmed that this change was made in consultation with experts and patient advocates, who agreed that a single-pill option would be easier for patients to manage. The company emphasized its commitment to ensuring a seamless transition to Vyndamax by working closely with healthcare providers, payers, patients, and other stakeholders.

Market Implications and Patent Considerations

The discontinuation of Vyndaqel comes ahead of its expected patent expiration in 2028. Industry analysts from Jefferies suggest that this early switch could lead to slower-than-expected erosion of the tafamidis franchise following Vyndaqel's generic entry. By the time generics enter the market, clinical use of the Vyndaqel formulation may already be minimal, potentially reducing the impact of generic competition.

Vyndamax currently enjoys US patent protection for its crystalline form until 2035, although this polymorph patent is being challenged. The tafamidis family has been a significant growth driver for Pfizer, with the franchise delivering 65% sales growth to reach $5.45 billion in annual revenues last year.

Competitive Landscape in ATTR-CM Treatment

Pfizer's move comes amidst an increasingly competitive landscape for ATTR-CM treatments. The FDA recently approved BridgeBio's rival TTR stabilizer Attruby, while Alnylam's RNA interference therapy Amvuttra has shown strong initial uptake since its launch.

Alnylam reported that approximately 1,400 ATTR-CM patients have started treatment with Amvuttra since its FDA approval in late March, generating about $150 million in revenue in the second quarter. Meanwhile, Pfizer's Vyndaqel family grew at 21% year over year in the same quarter, with sales reaching $1.62 billion.

As the ATTR-CM treatment landscape evolves, patients and healthcare providers will have a range of options to consider, including oral medications like Vyndamax and Attruby, as well as Amvuttra's subcutaneous injection administered once every three months by a healthcare professional.