Sanofi manufacturing glitch yields insulin pen shortage

Citing a "technical incident" at a manufacturing plant in Frankfurt, Germany, Sanofi ($SNY) reports that a worldwide shortage of the Apidra Solostar insulin pen will begin this month. The incident, which involved the production of the pens but not the short-acting drug, occurred in July.

"An in-depth investigation and additional controls were immediately carried out," the company informed doctors in a letter now posted on the FDA website. "We have proactively notified" the FDA of the event.

Competing products are widely available in the U.S., Dow Jones reports.

The letter also says Sanofi expects to return to normal supply levels by the first quarter of next year. In the meantime, the company recommends that doctors consider switching patients to Apidra vials and syringes. The product currently on the market is safe, the letter says.

- here's the letter (.pdf)
- see this story

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.