Five-Plus-Five Equals A Focus On Execution At Lilly In 2023

Approvals Near For Four New Drugs, One New Indication

Executives told Scrip the company is ready to move five programs into Phase III and launch five products this year, including an obesity indication for Mounjaro, but one drug has since received a CRL.

Office building at Lilly's Indianapolis HQ
Lilly's donanemab setback still could result in a win with positive Phase III data in Q2 • Source: Shutterstock

The theme for Eli Lilly and Company this year is “five-plus-five” as it prepares for five launches – four new medicines and a new obesity indication for diabetes therapy Mounjaro (tirzepatide) – and takes five candidates into Phase III trials. The company will have to remain focused on execution across multiple therapeutic areas, but chief scientific and medical officer Daniel Skovronsky and president of Lilly Diabetes Michael Mason said they believe their teams are up to the task, and that the existing experience in diabetes provides a strong base.

However, the week after Scrip spoke with Skovronsky, who is also president of Lilly Research Laboratories, and Mason at the J.P. Morgan Healthcare Conference in San Francisco, Lilly’s first anticipated launch of the year – the amyloid-clearing antibody donanemab for early Alzheimer’s disease – was grounded. The US Food and Drug Administration issued a complete response letter (CRL) rejecting the company’s application for accelerated approval of donanemab due to a lack of long-term data from enough patients

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