FDA approves Darzalex Faspro

2 May 2020

janssen_image_only_use_for_janssen_article_large

On May 1, the US Food and Drug Administration approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma, marking the first approval for this innovative subcutaneous formulation globally and providing a must faster form of administration.

This new product, from US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech, allows for subcutaneous dosing of daratumumab, marketed as Darzalex. J&J’s shares closed up 1.12% at $148.29 on Friday.

Janssen was granted an exclusive worldwide license to develop, manufacture and commercialize daratumumab by Denmark’s Genmab (Nasdaq: GMAB) in August 2012. Darzalex is already a blockbuster seller for the US company, having generated first quarter 2020 sales of $937 million, up 49% from the like, 2019 quarter.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK