Pharma meets AI and new obesity drug checks

Obesity drugmakers are pushing in two directions at once: Eli Lilly has started shipping its new daily weight-loss pill across the United States, and Novo Nordisk has enlisted OpenAI to speed up the next wave of treatments. (lilly.com) (cnbc.com) Lilly said on April 9 that Foundayo, the brand name for orforglipron, is available through LillyDirect, telehealth providers and retail pharmacies after the Food and Drug Administration approved it on April 1. The company said eligible commercially insured patients can pay as little as $25 a month, while self-pay pricing starts at $149 a month at the lowest dose. (lilly.com 1) (lilly.com 2) Foundayo is a glucagon-like peptide-1 pill, a medicine that mimics a gut hormone that helps people feel full and eat less, and Lilly says it can be taken once a day without food or water restrictions. In Lilly’s ATTAIN-1 trial, patients on the highest dose who stayed on treatment lost an average of 27.3 pounds, or 12.4% of body weight, versus 2.2 pounds on placebo. (fda.gov) (lilly.com) The Food and Drug Administration did not stop at approval. In Lilly’s approval letter, the agency ordered the company to finish an ongoing trial, called ACHIEVE-4, and submit added safety data on major adverse cardiovascular events and the potential for drug-induced liver injury. (fda.gov) The label also carries a boxed warning about thyroid C-cell tumors and says the drug is contraindicated for patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. The prescribing information also warns about pancreatitis and severe gastrointestinal reactions. (fda.gov) That scrutiny lands as obesity pills are moving the market beyond weekly injections. CNBC reported on April 7 that Novo Nordisk’s oral Wegovy rollout was drawing in patients who had avoided injectable drugs because of needle fears or out-of-pocket costs. (cnbc.com 1) (cnbc.com 2) Novo’s answer on April 14 was not another launch but a research deal. The company said its OpenAI partnership will use artificial intelligence tools to analyze large datasets, identify drug candidates and cut the time from research to patient use in obesity and diabetes. (cnbc.com) (pharmaceutical-technology.com) Novo Chief Executive Mike Doustdar said the goal is to find “new and better treatment options” faster, while OpenAI Chief Executive Sam Altman said artificial intelligence can help life sciences improve speed and efficiency. CNBC said Novo shares rose 2.8% shortly after the opening bell on Tuesday. (cnbc.com) Artificial intelligence is still far from designing and delivering a drug on its own, and Arthur D. Little partner Ben van der Schaaf told CNBC that clinical trials remain “very traditional” in many places. For now, the near-term picture is simpler: one company is widening access to a new obesity pill, and its rival is betting software can help build the next one. (cnbc.com)