German drugmaker Bayer is in talks with the FDA about marketing a low-dose version of the cholesterol drug Pravachol to consumers in the US without a prescription, Bloomberg News reports.
“The most recent dialogues we’ve had with the FDA in the spring are the most encouraging we’ve seen thus far and we’ll continue those,” Gary Balkema, head of Bayer’s consumer unit, told investors during a conference held last week.
Bayer owns the rights to the US consumer version of Pravachol, purchased from Bristol-Myers Squibb, and said it plans to shoulder the cost of the product’s development.
Bayer is planning to succeed where Merck and Bristol-Myers Squibb have failed in the past.
In 2000, the FDA rejected requests Merck, which sells Mevacor and Bristol-Myers Squibb which owns Pravachol. Both companies sought to sell low-dose OTC versions of their products. In 2005, the agency rejected a second try by Merck and Johnson & Johnson saying research did not show an OTC version of Mevacor would be used safely.
Meanwhile, Merck’s statin Zocor has been available in the UK since 2004 with pharmacists having the ability to decide whether the consumer gets the medicine.
Approximately $22 billion is spent globally each year on cholesterol lowering medicines.
