Summary
- Pfizer obtained FDA approval for drugs Vyndaqel and Vyndamax to treat patients with transthyretin amyloid cardiomyopathy.
- Vyndaqel and Vyndamax are the first drugs approved to treat ATTR-CM specifically, with potential competition in the future stemming from Alnylam and possibly Ionis with partner Akcea.
- Analysts estimate that Pfizer's drugs for ATTR-CM could generate as much as $2 billion in peak sales so long as a strong marketing plan and patient education are implemented successfully.
- Approval of tafamidis was given by the FDA on the basis of a positive phase 3 study, in which the drug proved to be stat sig over placebo in both all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo.
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Pfizer (PFE) was able to obtain FDA approval for its drugs by the name of Vyndaqel and Vyndamax (tafamidis) to treat patients with transthyretin amyloid cardiomyopathy. This is a good approval for the company because it has given itself a great opportunity to target a space with no competition for a few years. However, there are several competitors that have already received approval for a disease closely similar to ATTR-CM. This remains as a major risk to potential sales for both Vyndaqel and Vyndamax.
