STAT+: Pharmalittle: We're reading about FDA plans to ban a cold med; Eisai Alzheimer's drug sales, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We expect to continue the never-ending quest to manicure the Pharmalot grounds, promenade with the official mascots, and catch up on napping. We also hope to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This remains a fine time to enjoy the great outdoors. While doing so, you can ponder upcoming holiday plans — who to visit and who to avoid, that sort of thing. Or you could simply plan the rest of your life, given recent events. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The U.S. Food and Drug Administration proposed removing oral phenylephrine, widely used in cold and cough syrups, as an active ingredient in over-the-counter drugs for nasal congestion, stating it is not effective, Reuters says. Phenylephrine is widely used in a variety of over-the-counter flu and cold medicines, including popular products such as Benadryl, Advil, and Tylenol. It is also an ingredient in nasal sprays to treat congestion. However, the FDA action is only related to orally administered phenylephrine and not the nasal spray form. Last year, an FDA advisory panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise. Procter & Gamble, GSK, and other companies were accused in lawsuits of deceiving consumers about cold medicines containing the ingredient.

Eisai has retreated from its optimistic view of sales growth for Alzheimer’s disease drug Leqembi as uptake remains sluggish, Pharmaphorum tells us. In its six-month financial report for the current fiscal year published this morning, the company revealed Leqembi sales were around $107 million, with nearly two-thirds coming from the U.S. That prompted Eisai to reduce its fiscal 2024/25 projections for the drug to $279 million after an encouraging start to the year. So far, the drug has been launched in the U.S. and five other countries, but prospects were recently dashed after regulators in the European Union and Australia indicated they were not likely to issue approvals because efficacy did not outweigh the risk of side effects. And recent reimbursement decisions have not gone well. The health technology assessment agency for England and Wales recently rejected National Health Service coverage, in part due to costs for monitoring for side effects.

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