Boehringer Ingelheim's Obesity Drug Shows 16.6% Weight Loss in Clinical Trial

Boehringer Ingelheim's experimental obesity drug achieved 16.6% weight loss in clinical trials, entering the competitive GLP-1 weight loss market. Meanwhile, the FDA is taking enforcement action to withdraw approval of Amgen's rare-disease drug Tavneos, approved in 2021, citing new evidence of ineffectiveness and untrue statements in the approval application, while Amgen refuses voluntary withdrawal and insists the drug is safe. Novartis reported declining first quarter sales and operating profit due to generic competition hitting drugs like Entresto, though the company affirmed full-year guidance with low single-digit sales growth expected. Separately, Eli Lilly announced a partnership with AI-focused biotech Profluent to develop gene editors capable of inserting entire genes into patients.

Boehringer Ingelheim's Obesity Drug Clinical Trial Results

• ▪Boehringer Ingelheim's obesity drug showed 16.6% weight loss in a clinical trial.

Novartis Financial Performance and Generic Competition

• ▪Novartis core operating profit is forecasted to decline slightly for the year.
• ▪Novartis shares were down in early trading after the company reported a drop in sales and operating profit in the first quarter.
• ▪Generic competition hit Novartis drugs like Entresto hard.
• ▪Novartis affirmed its guidance for the year with net sales expected to grow in the low single digits.

FDA Actions Against Amgen's Tavneos

• ▪The FDA stated that the application used to support Tavneos approval contained untrue statements of material fact.
• ▪The FDA stated that new information indicates Tavneos is ineffective.
• ▪The FDA has taken further actions to withdraw the approval of Amgen's rare-disease drug Tavneos and remove it from the market.
• ▪Amgen insists that Tavneos is safe.
• ▪Amgen has refused to withdraw Tavneos voluntarily.

Eli Lilly's Gene Editing Partnership with Profluent

• ▪The gene editors being developed by Eli Lilly and Profluent are potentially capable of inserting entire genes into patients.
• ▪Eli Lilly announced a deal with AI-focused biotech Profluent to develop new forms of gene editors.

Perspective of Amgen

• ▪Amgen maintains that Tavneos is safe for patient use.
• ▪Amgen refuses to voluntarily withdraw Tavneos from the market despite FDA requests.

Perspective of FDA

• ▪The FDA is pursuing withdrawal of Tavneos approval after Amgen declined voluntary withdrawal.
• ▪The FDA concluded that new information demonstrates Tavneos is ineffective for its approved indication.

Perspective of Novartis

• ▪Novartis expects net sales to grow in the low single digits for the full year despite first quarter declines.

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