Indianapolis-based Eli Lilly and Co. (NYSE: LLY) has received priority review from the U.S. Food and Drug for the New Drug Application for selpercatinib, which treats people diagnosed with small cell lung cancer and some thyroid cancers. The company also announced financial results for the fourth quarter and full year 2019.
The FDA has filed the NDA and set a Prescription Drug User Fee Act date for the third quarter of this year.
“We are pleased the FDA granted priority review status for the NDA for selpercatinib. This represents an important step toward providing a new precision therapy for people living with certain RET-driven cancers,” said Anne White, president of Lilly Oncology. “Combined with the recent opening of our two Phase 3 selpercatinib clinical trials, we are thrilled with the positive momentum of this program and hope to deliver a practice-changing treatment to patients with RET-driven cancers as soon as possible.”
Lilly is reporting a fourth quarter net income of nearly $1.5 billion, up from $1.1 billion during the same time during the previous year.
Officials from the company say the increase in net income in the fourth quarter of 2019 was due to higher operating income and higher other income, which was partially offset by higher income taxes.
Additionally, earnings per share in the fourth quarter of 2019 were impacted from lower weighted-average shares outstanding following the Elanco exchange offer and share repurchases.
For the full year 2019, Lilly is reporting a net income of $8.3 billion, compared with $3.2 billion in 2018. These increases were due to the gain recognized on the disposition of Elanco as well as higher operating income, according to the company.
“Lilly is in the early phase of an exciting period of growth for the company. The combination of strong revenue growth from our newer medicines and prudent expense control across our business enabled Lilly to invest more in our R&D pipeline and still deliver impressive earnings growth in the fourth quarter and full-year 2019,” said David Ricks, Lilly’s chairman and chief executive officer. “We look forward to continuing this progress in 2020, as our scientists work to expand our portfolio of innovative medicines to offer new treatment options for patients in the areas of diabetes, oncology, immunology, and neuroscience.”