Pfizer Faces New Competition in ATTR-CM Market as Alnylam and BridgeBio Enter the Fray​.

Pfizer's stronghold in the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) is encountering significant competition with the recent approvals of new therapies from Alnylam Pharmaceuticals and BridgeBio Pharma.​

For five years, Pfizer's tafamidis, marketed as Vyndaqel and Vyndamax, was the sole FDA-approved treatment for ATTR-CM, a rare and fatal heart condition characterized by the accumulation of misfolded transthyretin proteins in the heart.​

In November 2024, BridgeBio received FDA approval for its oral drug, acoramidis (brand name Attruby), offering a new option for patients. Subsequently, in March 2025, Alnylam's injectable therapy, vutrisiran (marketed as Amvuttra), also gained FDA approval for ATTR-CM, expanding its prior approval for treating polyneuropathy associated with hereditary ATTR amyloidosis.​

ATTR-CM leads to heart muscle stiffening and heart failure, with a median survival of approximately 2.5 years without treatment. BridgeBio estimates that around 240,000 individuals in the U.S. are affected by ATTR-CM, indicating a substantial market for these therapies.​

Pfizer reported $5.4 billion in tafamidis sales in 2024, a 60% increase from the previous year. However, with new entrants in the market, Pfizer anticipates a moderation in growth. Chief Financial Officer David Denton acknowledged that Vyndaqel's growth would be tempered due to the impact of the Inflation Reduction Act and increased competition in the U.S.​

Despite the emerging competition, Pfizer CEO Albert Bourla remains confident in retaining market share, emphasizing the company's established network and physician familiarity with its products. He stated that physicians are unlikely to switch patients from a medication that is working effectively.​

Alnylam, however, aims to position Amvuttra as the new standard of care. CEO Yvonne Greenstreet highlighted the drug's potential, noting that patients may prefer an injectable therapy that addresses the underlying cause of the disease. Chief Commercial Officer Tolga Tanguler added that Amvuttra's quarterly subcutaneous dosing could be more convenient for patients.​

Alnylam projects combined sales of Amvuttra and its other approved drug, Onpattro, to reach between $1.6 billion and $1.725 billion in 2025, marking a 36% increase from the previous year. Amvuttra is priced at an annual list price of $476,000, higher than Pfizer's tafamidis at $268,000 and BridgeBio's Attruby at $244,500. Alnylam plans to reduce the net price through rebates and value-based agreements as prescription uptake grows.​

The Inflation Reduction Act may influence patient costs, capping Medicare Part D out-of-pocket spending at $2,000. Amvuttra, classified as a Medicare Part B drug, involves a 20% coinsurance, with Medicare Advantage plans capping annual costs at $9,350.​

To enhance accessibility, Alnylam is working to establish treatment sites within 10 miles of 90% of patients, focusing on the 170 health systems where 80% of ATTR-CM patients receive care. As of March 20, the company had nearly 2,000 alternate sites of care.​

BridgeBio, emphasizing the convenience of oral medication, argues that many ATTR-CM patients, often seniors, may prefer an oral therapy over injectable options. Chief Commercial Officer Matt Outten noted that patients already managing multiple medications might find it easier to incorporate another pill into their routine.​

In the initial two months post-launch, BridgeBio's Attruby exceeded expectations, with approximately 500 healthcare providers prescribing the drug to over 1,000 patients. Analysts predict first-quarter sales between $7 million and $14 million, surpassing the consensus forecast of

Looking ahead, Pfizer's tafamidis is set to lose patent protection in the U.S. in 2028, potentially opening the market to generic versions. However, Pfizer is developing a new tafamidis tablet formulation, currently in Phase I trials, which could extend patent protection through 2043. This move suggests that Pfizer anticipates sustained market presence beyond the upcoming patent expiration.​

With Alnylam, BridgeBio, and Pfizer all actively competing in the ATTR-CM market, and generic manufacturers poised to enter, the landscape is set for intensified competition, offering patients more treatment options and potentially driving innovation in this therapeutic area.

Source:https://www.biospace.com/business/pfizer-mounts-defense-of-cardiac-blockbuster-as-alnylam-bridgebio-enter-market

This is non-financial/medical advice and made using AI so could be wrong.