Pfizer obtains FDA approval for oral heart drug costing $225K a year

In May the drug received FDA breakthrough status and had lowered the risk of death for patients by 30% as compared to placebo

The U.S. Food and Drug Administration has recently approved tafamidis, an oral drug from Pfizer Inc for treating a fatal and rare heart disease named transthyretin amyloid cardiomyopathy.

Supposedly, Pfizer, which has advertised tafamidis as a potentially bestseller product, has set a market price of $225,000 per year for the medicine and it would be sold under the product name Vyndaqel. In the United States, this is the first approved medicine for the disease.

According to Refinitiv data, analysts are predicting annual sales to surpass $1 billion by 2024. Under the brand name Vyndamax, the FDA also formally approved another oral formulation of tafamidis with a recommended dose of either Vyndamax 61 mg once per day, taken as a single capsule or Vyndaqel 80 mg once per day, taken as four 20 mg capsules.

Head of rare disease at Pfizer, Paul Levesque, said that there were three important factors the company took into consideration for this price- population growth, the transformative nature of this compound, and company’s potential to ramp up diagnosis over time.

As per Pfizer, there are about 100,000 people in the United States with this condition and the majority of people are undiagnosed. It is estimated that only about 2,000 to 5,000 patients are presently diagnosed with progressive heart disease worldwide.

Apparently, in May the drug received FDA breakthrough status and had lowered the risk of death for patients by 30% as compared to placebo in clinical trials.

Reportedly, Vyndaqel presently sells for around $100,000 yearly outside the United States as a treatment for FAP. In May, it was also officially approved in Japan for transthyretin amyloid cardiomyopathy at a list price of about $750,000 yearly that was determined by a government authority.

In addition, Ionis Pharmaceuticals Inc and Alnylam Pharmaceuticals have approved medicines that treat a similar disease named hereditary TTR amyloidosis. Those drugs are priced at about $450,000 yearly.

Source credit: https://www.reuters.com/article/us-pfizer-approval/pfizer-gets-u-s-approval-for-225000-a-year-heart-drug-idUSKCN1SC0VX