Johnson and Johnson submit new formulation of Darzalex to fend off rivals

Darzalex has recorded $775m in the second quarter of this year,
showing no signs of slowdown, four years after its initial approval

J&J has submitted for approval in Europe and the US a subcutaneous injection version of its multiple myeloma drug Darzalex, that would significantly increase ease of dosing for patients and help to defend its franchise from Sanofi rival.

This new formulation, if approved, would result in Darzalex being able to be administered to patients in a few minutes compared to the current intravenous infusion process taking several hours. Not only would this provide an increase in comfort and ease for patients, but it also provides the extra advantage of Darzalex being provided in a community setting rather than the current hospital trip that is necessary.

J&J has submitted phase three trial results that show the subcutaneous formulation is just as effective as the IV Darzalex on myeloma response rates and also shows that seems to cause fewer infusion-related reactions.

J&J hopes that this new formulation will be approved, as it will help to fend off competition from rival Sanofi, which also has recently submitted for approval its candidate isatuximab. Sanofi could take a chunk of the market as it is a treatment that is delivered in a two-hour intravenous fusion. With Sanofi also stating that it is safer to use in patients with inflammatory diseases like asthma, as compared with Darzalex it is not associated with complex activation.

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