Regulatory Index News: 20/05/2018

Welcome to your Regulatory Index News update today, which includes positive trial results in the treatment of migraine and adolescent atopic dermatitis and an EU approval in the kidney cancer setting. Read here to keep up to date.

​Ipsen’s Cabometyx given green light in the EU 

An approval by the European Commission for first-line treatment of adults with advanced renal cell carcinoma (RCC) was granted to Ipsen/Exelixis for their Cabometyx (cabozantinib) drug. Data from the CABOSUN trial shows that Cabometyx prolongs progression-free survival (PFS) in treatment-naive RCC patients with intermediate or poor risk disease, with a 52% reduction in the hazard for progression or death when compared with those treated initially with Pfizer's Sutent (sunitinib) drug. Please click here to read more from a PharmaTimes article.



Lilly's migraine drug showing positive results

Eli Lilly's calcitonin gene-related peptide (CGRP) inhibitor drug galcanezumab had a significant result in reducing the amount of weekly cluster headache attacks for patients who experience these intertmittently. According to data released by Eli Lilly on 15 May 2018, patients on the study drug in their Phase 3 trial had 8.7 fewer attacks of episodic cluster headaches compared to 5.2 fewer attacks for those on placebo during a 3 week treatment period. Patients with chronic cluster headache underwent a separate Phase 3 study, which represents 10 to 15 precent of cluster headache cases, but this did not meet its primary endpoint. Lilly is expecting a decision from the FDA on the approval of its Biologics License Application for galcanezumab in the adult migraine prevention setting during the third quarter of 2018.  Please click here to read more from a BioPharmaDive article.

Adolescent atopic dermatitis targets hit in Dupixent trial

Sanofi and Regeneron's late-stage study of their Dupixent (dupilumab) drug in 251 patients aged 12 to 17 suffering moderate to severe atopic dermatitis met its primary endpoints, opening up the opportunity to file for treatment in this younger age group in the third quarter of this year. Twenty-four percent of patients receiving weight-based dosing of Dupixent every 2 weeks and 18% of those given a fixed dose every four weeks acheived the primary endpoint of clear (0 on the Investigator's Global Assessment (IGA)) or almost clear (1 on the same IGA scale) skin when compared to 2% in the placebo arm. Please click here to read more from a PharmaTimes article.



Lorna Osborn

Date Published

20th May 2018

Come and join our community!

We are ready and waiting for you

We use cookies. By continuing to browse the site or closing this message you are agreeing to our Terms and Privacy Policy

ACCEPT and Hide This Message