Following recent recalls of blood pressure medicines in North America, Pfizer has run into another drug manufacturing problem—this time in Asia.
Pfizer halted the supply of rare disease med Vyndaqel in Korea because of a quality problem, Korea Biomedical Review reports.
“Internal inspection revealed a minor packaging issue with one batch of the medicine which was discarded before being released to the market,” a Pfizer spokesperson told Fierce Pharma via email. “The issue is considered resolved.”
The spokesperson didn’t say which manufacturing plant provided the faulty products. Pfizer Korea receives Vyndaqel from facilities in Belgium, the U.K. and the U.S., according to Korea Biomed. The problem didn’t impact supplies in the U.S. or the EU, the spokesperson added.
The drug is one of two sister meds using the active ingredient tafamidis that collectively reeled in over $2 billion sales globally in 2021, good for 56% year-over-year growth.
Vyndaqel, offered in 20-mg pills, is approved in Korea to treat transthyretin amyloidosis (ATTR) polyneuropathy, a rare disease that affects the peripheral nerves. The product halt doesn’t affect Vyndamax 61-mg capsules, which are allowed in the country for ATTR cardiomyopathy, a heart-related disease and more prevalent subtype of ATTR, Korea Biomedical Review reports.
Pfizer has reported a Vyndaqel supply shortage to Korean authorities, Korea Biomed reports, citing industry insiders. A query of the U.S. FDA’s drug shortages database Monday morning returned no results for tafamidis.
In the U.S., the tafamidis drugs are only approved for ATTR cardiomyopathy, and one Vyndamax 61-mg capsule is bioequivalent to four Vyndaqel 20-mg capsules.
The Vyndaqel packaging snafu adds to Pfizer’s drug manufacturing problems lately. Earlier this year, Pfizer recalled some of its long-acting blood pressure med Inderal from Canada, citing high levels of likely cancer-causing impurities. It also pulled some of its blood pressure drug Accuretic and a pair of its generic hypertension meds off the U.S. shelves in March. High levels of carcinogens represent an industrywide problem that has affected many companies’ prodcuts across different therapeutic areas over the past few years.
Last year, Pfizer made rounds of recalls globally of its smoking cessation drug Chantix, including in Korea, where it’s known as Champix.