Federal regulators are reportedly set to formally approve Pfizer’s use of the drug Namenda XR in the largest known use of the medication – to treat chronic moderate to severe dementia. The Food and Drug Administration would sanction the move before the end of the month, allowing Pfizer to make the drug available to all adults.
According to Reuters, it would also make the drug the most widely used in the world. The current market leader is Eli Lilly’s Apoquel, which is only approved for adults with Alzheimer’s disease, even though in many cases, there is no evidence that the drug benefits patients. The FDA would also approve Pfizer’s Valcyte for use in adults with Cushing’s syndrome, but there are no currently approved medications in the United States for that particular condition.
Earlier this month, the U.S. Department of Health and Human Services published a statement encouraging “access to innovative therapies that may help mitigate the impact of…dementia.” (The statement noted that Pfizer’s Namenda XR may help patients with severe and persistent dementia who have been rejected for “more expensive” clinical trials.)
In theory, such a move – for all adults with mild to moderate dementia – could save the U.S. government money, as federal expenditures for Alzheimer’s related care have increased at a much faster rate than the rate of the increase in the actual population of those with the disease. But using experimental drugs for these types of patients is both a tricky exercise and a risk, as any adverse reactions to Namenda XR will have to be taken into account when the FDA approves the drug.
Pfizer has been testing Namenda XR for four years. According to the FDA submission, the drug provides significant benefit for patients who have failed other Alzheimer’s treatments and who may be at higher risk of developing dementia – it is noted in the document that 33 percent of patients who did not respond to traditional dementia medications have also not responded to Namenda XR.
Multiple other specific indications also received FDA approval this week. U.S. health regulators also made approvals for Upadacitinib, an anti-rheumatoid arthritis drug developed by Amgen, and leucovorin, a drug from Bristol-Myers Squibb that works against lipids that can cause cardiovascular disease. As reported by Reuters, the FDA also approved a number of other drugs, including one to treat rheumatoid arthritis by Eli Lilly, another to treat infections caused by trichomes by Merck, and another to treat a rare disease of cats and dogs that can damage organs.
Read the full story at Reuters.
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