Eli Lilly's New Medication for Adults Receives FDA Approval
On Thursday, Eli Lilly and Co (LLY:US) announced that the U.S. health regulator had granted approval for its medication aimed at treating adults with moderate-to-severe active ulcerative colitis, a form of chronic inflammatory bowel disease.
This approval was granted based on data derived from late-stage clinical studies of the drug, which demonstrated its effectiveness in alleviating the symptoms of the disease in comparison to a placebo.
The drug will soon be available in the United States under the brand name “Omvoh” and can be considered one of the potential growth drivers for Lilly in the current decade. Other products in this category include tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema, and pirtobrutinib for cancer.
This regulatory decision will enable Lilly to enter a sector where competing drugs from pharmaceutical companies such as Abbvie Inc (ABBV:US), Pfizer Inc (PFE:US), and Johnson & Johnson (JNJ:US) already have a presence and are competing for a share of the multi-billion dollar market.
Back in April, the U.S. Food and Drug Administration (FDA) had initially denied clearance due to concerns related to the proposed manufacturing processes of the treatment. However, Lilly successfully managed to fulfill all the health concerns raised. The company also successfully obtained approval for the drug in Japan and the European Union earlier this year.
On Thursday, the company's stock saw a modest increase of nearly 0.5% during extended trading hours.
Talking about congressional views regarding the pharma stock, several lawmakers were seen increasing their stakes in the company including Senator Sheldon Whitehouse and Markwayne Mullin as well as Congressmen John Curtis, Josh Gottheimer, and Ro Khanna.
