Pfizer will discontinue Vyndaqel, its low-dose ATTR-CM therapy, in the U.S. by late 2025, shifting all patients to Vyndamax. Learn why Pfizer made the decision, how it impacts patients, and what it means for the ATTR-CM treatment market.
Pfizer has confirmed that it will withdraw its low-dose ATTR-CM therapy Vyndaqel from the U.S. market by late 2025, three years before the drug’s patent expiration in 2028. The decision, communicated through patient advocacy groups in early September and later confirmed by the company, marks a significant shift in the pharmaceutical giant’s tafamidis franchise. Once the transition is complete, Vyndamax will remain the sole tafamidis formulation available in the United States.
From Vyndaqel to Vyndamax
Both Vyndaqel and Vyndamax were approved by the FDA in 2019 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive and life-threatening disease in which misfolded transthyretin proteins deposit in the heart. The two drugs share the same active ingredient, tafamidis, but differ in their formulations. Vyndaqel is taken as four 20 mg capsules daily, while Vyndamax simplifies treatment to a single 61 mg capsule once a day.
From the outset, physicians and patient groups viewed Vyndamax as the more convenient option. Reducing the pill burden to one capsule a day makes adherence easier, particularly for elderly patients managing multiple medications. Pfizer has repeatedly emphasized that the discontinuation of Vyndaqel is intended to streamline treatment and improve the patient experience, a view echoed by experts and advocacy organizations who were consulted before the decision was finalized.
Strategic Timing Ahead of Patent Expiration
Although Pfizer frames the transition as patient-centered, industry analysts see a clear strategic calculation. Vyndaqel’s U.S. patent expires in 2028, which would have opened the door to generic competition. By phasing the drug out three years earlier, Pfizer is effectively minimizing the relevance of any forthcoming generics. Analysts at Jefferies noted that by the time generic Vyndaqel could enter the market, there may be little clinical use for the formulation, making it unlikely to have much impact.
Vyndamax, by contrast, enjoys U.S. patent protection until 2035 thanks to a crystalline polymorph patent. That protection is being legally challenged, but as long as it holds, it gives Pfizer nearly a decade more exclusivity for its tafamidis franchise. The move to consolidate all prescriptions under Vyndamax strengthens Pfizer’s position by directing patients to the formulation with the longer lifespan on the market.
Sales and Market Performance
The tafamidis family has become one of Pfizer’s most important growth drivers. In 2024, the franchise brought in $5.45 billion in annual revenue, a 65 percent increase compared with the previous year. In the second quarter of 2025 alone, tafamidis sales reached $1.62 billion, reflecting 21 percent year-over-year growth.
Despite Vyndaqel’s withdrawal, the financial impact for Pfizer is expected to be limited. Prescription data show that less than 20 percent of tafamidis use in the United States is still tied to Vyndaqel, with the majority of patients already transitioned to Vyndamax. The decision to pull the low-dose version is therefore more of a formal conclusion to a process that has been underway for several years.
Growing Competition in the ATTR-CM Space
Pfizer’s dominance in ATTR-CM treatment is no longer uncontested. In November 2024, BridgeBio received FDA approval for Attruby (acoramidis), a transthyretin stabilizer administered orally once a day. Around the same time, Alnylam advanced its RNA interference therapy Amvuttra (vutrisiran), which reduces transthyretin production in the liver. Amvuttra is administered by subcutaneous injection every three months and has quickly gained traction, with more than 1,400 patients initiating treatment by mid-2025 and generating about $150 million in second-quarter revenue.
The entrance of these competitors has raised questions about how Pfizer will maintain its market share. Some physicians have even explored combination use of tafamidis with Amvuttra, though reimbursement challenges have so far limited the practice. Analysts suggest that once generic tafamidis becomes available, combination therapies may become more common, as payers could be more willing to support them when cost barriers are reduced.
Implications for Patients and Providers
For patients currently on Vyndaqel, the transition should be straightforward. Pfizer is working closely with physicians, payers, and patient groups to ensure a smooth handoff to Vyndamax. Since both drugs contain the same active ingredient and provide equivalent efficacy, the switch is largely a matter of convenience and dosing schedule. Patients will benefit from fewer pills and potentially better adherence, while physicians and pharmacists will have a clearer prescribing pathway.
Globally, Vyndaqel will continue to be available in certain markets where Pfizer has not yet fully transitioned its tafamidis portfolio. But in the U.S., the discontinuation signals a decisive shift in the company’s strategy to focus exclusively on Vyndamax.
Looking Ahead
Pfizer’s decision to withdraw Vyndaqel before its patent expiration in 2028 illustrates the delicate balance between patient-focused care and long-term commercial strategy. By eliminating the lower-dose option, Pfizer simplifies the patient experience, while also steering its multibillion-dollar tafamidis franchise away from looming generic competition.
At the same time, the company faces mounting challenges from new entrants such as Attruby and Amvuttra, which are reshaping the ATTR-CM treatment landscape. With patent litigation on the horizon and payer dynamics evolving, Pfizer will need to defend both the clinical and commercial value of Vyndamax in an increasingly competitive field.
For now, the company retains a strong advantage, as tafamidis remains the standard of care and continues to generate impressive sales growth. But the next decade will determine whether Pfizer can maintain its leadership in a therapeutic area that is becoming more crowded and more innovative.
