STAT+: Pharmalittle: We're reading about a Merck drug-label controversy, Astellas pulling an application, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online calls, and meetings has resumed. But what can you do? The world, such as it is, continues to spin, however wobbly it may feel. So to cope, yes, we are firing up the trusty coffee kettle in brewing another cup of stimulation. Our choice today is butter pecan. As always, you are invited to join us. Meanwhile, here are a few tidbits to digest while you are quaffing. We hope your day is meaningful and productive. And of course, please do keep in touch. We appreciate the interaction. …

A drug used to combat fungal infections in cancer patients comes with a big caveat — research shows the medicine can last twice as long in people with obesity. This means chemotherapies may be less effective when interacting with the medicine, but some clinicians, and their patients, are unaware of that possibility, STAT explains. The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population. And the company has refused to update the language. At issue is a medicine called posaconazole that was approved in 2006 in the U.S. but is now also sold by generic companies. As the original brand-name manufacturer, however, Merck continues to have legal responsibility for the labeling, which means that all available versions lack the details. And some clinicians argue this compromises safety and effectiveness for cancer patients who are also obese.

Astellas will withdraw its filing with the European Medicines Agency for a drug used to treat geographic atrophy, an eye disorder, based on feedback from the regulator, Pharmaphorum writes. The decision is a major setback for a program that lay at the heart of Astellas’ $5.9 billion acquisition of the drug’s developer Iveric Bio last year. Astellas said the move follows interactions with the EMA’s human medicines committee, the CHMP, adding that it remains “fully committed” to eventually bringing the drug, called avacincaptad pegol, to market in Europe. It is a different story for the company in the U.S., where the treatment was approved last year for GA secondary to age-related macular degeneration, a leading form of blindness. That approval set up a market clash with Apellis Pharma’s complement C3 inhibitor Syfovre, which was cleared a few months earlier. There are currently no approved treatments outside of the U.S. for GA associated with AMD.

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