At a stroke, it’s got a product authorized for a specific use in 27 countries.
Tandem Diabetes Care (TNDM 4.25%) had some encouraging news to report on the regulatory front Thursday, and after it hit the headlines investors piled into the stock. At the end of the day the highly specialized healthcare company’s share price had risen in excess of 4%, good enough to top the 1.7% rise of the benchmark S&P 500 index.
Crucial approval granted
Tandem announced Thursday morning that it had won an important approval from the European Union’s (EU) European Medicines Agency (EMA). The green light was turned on for the company’s t:slim X2 automated insulin delivery (AID) pump to be used to deliver Eli Lilly‘s (LLY 1.11%) Lyumjev — an ultra-rapid acting insulin product.
Although Lyumjev earned its approval in the 27-nation body back in 2020, the stringent testing the EU requires of pump manufacturers meant Tandem’s product needed some time to catch up. Eli Lilly and Tandem teamed up to test the former’s insulin product with the latter’s delivery system.
In its press release trumpeting the EU’s move, Tandem quoted its chief medical officer Jordan Pinsker as saying, “Ultra-rapid-acting insulin is a popular choice for people living with diabetes due to its fast response time. We are proud to be able to offer Lyumjev compatibility with our t:slim X2 pump as part of an AID system in the EU, providing more flexibility for our customers in these countries.”
Continuing on their regulatory quest
Approval in a jurisdiction as large and sprawling as the EU is a very positive step for any healthcare company. Emboldened by their win, Tandem and Eli Lilly plan to apply for Lyumjev comparability with Tandem’s delivery systems in other markets around the globe.
Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
