‘Aspire’ – for everyone: Pfizer seeks approval for cholesterol pills

Regulators Now Want to Improve Evidence that Drug is Effective in Aged Adults Pfizer Inc., the world’s largest maker of drugs for major chronic diseases, said Wednesday it has asked the US Food and…

‘Aspire’ – for everyone: Pfizer seeks approval for cholesterol pills

Regulators Now Want to Improve Evidence that Drug is Effective in Aged Adults

Pfizer Inc., the world’s largest maker of drugs for major chronic diseases, said Wednesday it has asked the US Food and Drug Administration to allow any adult, regardless of age, to take its new nutritional cholesterol pill if it is recommended by a physician.

In January, Pfizer, the Connecticut-based drugmaker with about 55,000 employees worldwide, said the FDA, under a fast-track review, cleared its popular chronic heart disease drug, ibrutinib, for use in a reduced-intake study of low- and middle-aged adults. But it, the FDA and Pfizer have been divided on the health benefits of a whole new class of cholesterol pills, which include the low-dose statin and revolutionary PCSK9 inhibitor from the French drugmaker Regeneron Pharmaceuticals.

New York-based Pfizer, with a market value of $276bn, is also hoping to prove to the FDA that its “asthma drug” palbociclib (sold as Olmesartan in the US) can expand beyond patients with the very rare condition of advanced endometrial cancer. In the colorectal cancer trials, palbociclib was effective without causing much side effects, but given to a broad patient population for its potential to prevent or treat the disease, including third- and fourth-line treatment.

In an email to the Guardian, Pfizer said of its request for the approval of “Aspire” in adults, it wants “to expand access for adult patients to beneficial medicines”, and noted that they are studying the “objective clinical benefit” of dietary supplements (like Viagra) for the all-important benefits versus risks of other drugs like inbilect and ticagrelor.

So, Pfizer believes that there is “a compelling rationale to expand access to the combination, especially for patients who are currently not well served by the current options for treatment”, Pfizer said. “Pfizer has requested unrestricted access for Aspire, so that adult patients with chronic heart failure and/or glomerulonephritis – conditions in which inappropriate levels of C-reactive protein are often found – may benefit from Aspire, regardless of their age.”

Pfizer made no mention of how many patients might use the combined product.

In the statement, Pfizer said: “Our goal is to help prevent life-threatening heart and kidney diseases and reduce cardiovascular mortality.

We believe that further study will confirm the potential benefits of Aspire with the potential to have potential to prevent serious and often life-threatening conditions.”

In December, the drugmakers argued in a federal appeals court over a decline in sales of their blockbuster blood pressure pill, Lyrica, after all heart patients were placed on clinical trial monitoring groups after doctors lost confidence in its safety. Since then, the cholesterol pill may have held sales steady, if only because heart patients generally stay on prescription medicine for life. But sales of the blood thinner, Eliquis, which works by blocking the clotting protein and a chemical used in making drugs called thrombin, have tripled and are now expected to top $4bn this year.

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