BridgeBio poised to challenge Pfizer after Attruby approval

The FDA has approved BridgeBio Pharma's acoramidis for life-threatening heart disorder transthyretin amyloidosis cardiomyopathy (ATTR-CM), setting up a market showdown with its larger rival Pfizer.

Acoramidis has been cleared under the Attruby brand name as an oral therapy to reduce cardiovascular death and cardiovascular-related hospitalisation in adults with ATTR-CM, a progressive disease that leads to heart failure and death.

The labelling puts it in direct contention with Pfizer's blockbuster Vyndamax/Vyndaqel/Vynmac franchise – based on tafamidis – which has been approved for ATTR-CM since 2019 and is also used to treat polyneuropathy associated with ATTR (ATTR-PN).

ATTR is characterised by the formation of amyloid fibril deposits in tissues and organs – in the heart in the case of patients with cardiomyopathy – and both acoramidis and tafamidis drugs are designed to stabilise the TTR protein that misfolds in the disease.

Pfizer's range dominates the market with sales of $3.9 billion in the first nine months of this year, up two-thirds on the same period of 2023, but is in the last few years of its patent life.

Meanwhile, other companies are also targeting ATTR-CM, including Alnylam, which is hoping to get approval for its vutrisiran candidate next year, and AstraZeneca and Ionis' eplontersen. Both these are already approved to treat ATTR-PN, as Amvuttra and Wainua, respectively.

BridgeBio is pointing to the approved indication for Attruby as it gears up to launch the drug with a list price of $18,759 for a 28-day supply, saying it is the only drug with a label that says it can achieve "near-complete stabilisation of TTR."

The price is close to the average $225,000 annual cost of Pfizer's drugs, before any discounts or rebates, although, BridgeBio has said it will provide Attruby for free for the lifetime of any patient who participated in clinical trials of the drug.

In the ATTRibute-CM trial that supported Attruby's approval, the drug achieved a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalisations compared to placebo at 30 months.

BridgeBio's chief executive and founder, Neil Kumar, said the company's next tasks include pursuing regulatory approvals outside the US, starting with Europe – where it has already filed the drug, with a decision due next year – as well as Japan and Brazil.

Analysts have suggested that Attruby's profile could allow it to capture peak sales of $2 billion or more, with Mizuho Securities analyst Salim Syed predicting earlier this year that it could make as much as $4 billion a year.

Most analysts acknowledge that Alnylam's drug – which only needs to be given by a physician-administered subcutaneous injection every three months – could disrupt the current oral market. Goldman Sachs recently predicted that peak sales of vutrisiran could reach $5 billion.

In April, Bayer licensed European rights to acoramidis for $310 million in upfront and near-term payments, with BridgeBio in line for royalties in the "low-thirties" percentage range, while AstraZeneca has licensed the drug in the Japanese market.

BridgeBio also agreed a $500 million deal in January to sell a 5% share of royalties that became payable on FDA approval.