Pfizer is taking a curtain call for Vyndaqel, the low-dose version of its blockbuster tafamidis franchise for the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM).
Pfizer will discontinue Vyndaqel in the U.S. by the end of 2025, multiple amyloidosis patient groups alerted their members on social media earlier this month.
The move will leave the high-dose Vyndamax as the only tafamidis brand on the market.
“This decision was made to enhance patient-centered care and convenience as Vyndamax offers the same active ingredient and clinical benefits as Vyndaqel, but in a single capsule taken once daily, making it easier for patients to take their prescription,” according to the posts, which appear to be relaying a message from Pfizer.
A Pfizer spokesperson confirmed the decision to Fierce Pharma, saying the move will simplify the experience for patients and providers and avoid confusion.
“This change was made in consultation with experts in the field and patient advocates who agreed that a single-pill option is easier for patients to manage,” the Pfizer spokesperson said. “Pfizer is committed to ensuring a seamless transition to Vyndamax by working closely with healthcare providers, payers, patients, and other stakeholders.”
The drug’s price will remain the same, the spokesperson said.
The two tafamidis formulations were approved simultaneously by the FDA in 2019 to treat ATTR-CM. While Vyndaqel is given in four 20-mg capsules daily, Vyndamax comes as one 61-mg capsule per day.
Since its launch, the tafamidis family has been a major growth driver for Pfizer. Last year, the franchise delivered 65% sales growth to reach $5.45 billion in annual revenues.
The Vyndaqel market withdrawal is not a surprise. At the time of the FDA approval, Pfizer told Fierce Pharma that the company would aim to transition all patients to the more convenient Vyndamax once sufficient supply becomes available. Today, fewer than 20% of tafamidis scripts in the U.S. are for Vyndaqel, according to a Jefferies analysis of IQVIA data. The majority of patients in the U.S. are currently being treated with Vyndamax, including new patients, the Pfizer spokesperson told Fierce Pharma.
Pfizer is pulling the trigger on the full transition now as Vyndaqel is expected to lose patent protection in 2028. An early switch could lead to slower-than-expected erosion of the tafamidis franchise following Vyndaqel’s generic entry, Jefferies analysts observed in a Thursday note.
“By the time Vyndaqel generics enter the market, clinical use of the Vyndaqel formulation may already be minimal, reducing the relevance of generics,” the analysts said.
For its part, Vyndamax currently has U.S. patent protection for its crystalline form until 2035, although that polymorph patent is being challenged, the Jefferies team noted.
Pfizer is shoring up support for Vyndamax as competition intensifies in ATTR-CM.
The FDA in November approved BridgeBio’s rival TTR stabilizer Attruby. The initial launch of Alnylam’s RNA interference therapy Amvuttra also went significantly better than Wall Street had expected.
About 1,400 ATTR-CM patients have started treatment with Amvuttra since its FDA nod in late March, translating to about $150 million in revenue in the second quarter, Alnylam shared in its earnings update in July.
Meanwhile, Pfizer’s Vyndaqel family grew at 21% year over year in the second quarter, with sales reaching $1.62 billion during the period.
Between the three treatments, Vyndamax and Attruby are taken orally once daily and twice daily, respectively, while Amvuttra is injected subcutaneously once every three months by a healthcare professional.
Alnylam has also noted some combination use of Amvuttra and Vyndaqel, although the company doesn’t expect it to be a widespread practice because of potential payer challenges. That could change, however, when Vyndaqel generics enter the market in 2028.