Post

An oral obesity pill is among six drugs backed in Europe

Europe’s drug regulators recommended six new medicines at their October meeting, including an once-daily oral GLP-1 tablet for weight loss and diabetes and a new targeted drug for metastatic pancreatic cancer. The session also moved an overdose nasal spray to over-the-counter status.

Every month the European Medicines Agency’s expert committee meets behind closed doors, runs through the year’s applications, and comes out with a list of recommendations that quietly decides what patients in the bloc will be able to prescribe. At the session held from 12 to 15 October, and announced on 16 October, the committee backed six new medicines, and the spread says something about where drug development is heading.

The headline is a pill. The committee recommended granting a marketing authorization for Foundayo, the once-daily oral GLP-1 receptor agonist developed by Eli Lilly, for weight management and type 2 diabetes. GLP-1 medicines have reshaped obesity care over the past few years, but until now the best-known names have been injections, weekly or daily. An oral tablet that does the same job changes the practical equation for the large number of patients who dislike needles, and it widens the market far beyond the clinics that already run injectable weight-loss programmes. If the European Commission follows the recommendation, as it usually does, the oral route will bring GLP-1 treatment out of the specialist setting and into ordinary primary care.

The second striking recommendation is for a cancer drug with a narrow and grim target. Rasonque, daraxonrasib from Revolution Medicines, won a positive opinion for adults with metastatic pancreatic cancer after at least one prior treatment. Pancreatic cancer is among the hardest tumours to treat, and the drug was flagged through the agency’s Cancer Medicines Pathfinder, which fast-takes promising medicines against high unmet need. It is an orphan-style intervention aimed at a disease that has, until now, had little to offer patients who have run through the standard options.

The rest of the list rounds out the month. Yuviwel, navepegritide from Ascendis, is recommended for achondroplasia, the inherited growth disorder caused by a fibroblast growth-factor receptor 3 mutation that leaves children with very short stature. Two biosimilars, one a ranibizumab for eye disease and one a filgrastim for neutropenia, and a hybrid temozolomide for brain tumours completed the new approvals. Alongside the new drugs, the committee recommended reclassifying Nyxoid, the naloxone nasal spray used to reverse opioid overdose, so that it can be sold without a prescription, a small but meaningful step for the people who arrive first at an overdose.

The balance of the announcement tells the story of the field. Two of the most watched recommendations are not cures for rare diseases but broad-metabolic and common-oncology medicines aimed at huge populations. That is where the money and the science have both been going, and a regulator’s monthly list is the visible surface of that shift.

The honest caveats are built into the process. These are opinions, not final approvals, and the European Commission still has to sign off. Recommendations also come with the fine print of trials, side effects and which patients actually benefit. But for the patients waiting on an oral option or on a drug for a cancer that has run out of lines, a positive committee opinion is the first real gate.

This post is licensed under CC BY 4.0 by the author.