LONDON — A Novartis executive on Thursday said “it’s too early to say” whether the company would still submit an experimental myelofibrosis drug for regulatory approval this year, amid questions about the medicine’s data profile and whether it’s sufficient for filing.
Novartis had previously said it planned to submit a marketing application for a rare bone marrow cancer drug called pelabresib to the Food and Drug Administration this year. But on a call with reporters tied to the company’s second quarter earnings release, Harry Kirsch, the company’s chief financial officer, said Novartis was awaiting additional, longer-term data that would be available in the coming months.
Novartis picked up pelabresib through its nearly $3 billion acquisition of the German company MorphoSys, which was announced in February. The deal has closed and Novartis was making progress in absorbing MorphoSys, Kirsch said.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+.
Already have an account? Log in
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect