Regulatory Index News: 01/06/2018

Welcome to your Regulatory Index News update this Friday. Read here for stories on a new US approval for UCB, and two disappointing trial failures.

UCB announces US approval for Cimzia in psoriasis

Cimzia, UCB’s anti-inflammatory, has now been FDA approved for moderate-to-severe plaque psoriasis in adult candidates for systemic therapy or phototherapy, marking its entry into the immuno-dermatology. This adds to the drug's current indications in rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis and axial spondyloarthritis. The label expansion is based upon on a phase 3 trial programme (CIMPASI-1, CIMPASI-2 and CIMPACT) which enrolled over 1,000 patients. In each of the trials, Cimzia maintained statistically significant improvements in the primary and co-primary endpoints compared to placebo over a 48-week regimen. With an estimated 125 million people suffering from psoriasis worldwide, this gives them another important option. Please click here to read more on this from a PharmaTimes article.

AstraZeneca reports failure for its second Fasenra COPD trial

AZ has been investigating the label expansion of their asthma drug, Fasenra, into chronic obstructive pulmonary disease (COPD) with two phase 3 trials. However, on Wednesday, the drugmaker has reported its failure in the second trial (Terranova) where it could not meet its primary endpoint to significantly reduce episodes where symptoms suddenly worsened. The announcement comes after a similar one made earlier this month stating that Fasenra failed the other trial (Galathea). This now marks a major setback for the drug, which was hoped to dip into GSK’s COPD market. If you would like to read further into this, please click here for a FiercePharma article.

Darzalex/Tecentriq combo trial terminated by Janssen

J&J’s investigators have been forced to terminate a phase 1b/2 trial (CALLISTO/LUC2001) testing a combination of daratumumab (Janssen’s Darzalex) and atezolizumab (Roche’s Tecentriq) in patients with pre-treated metastatic non-small cell lung cancer. The data monitoring committee recommended trial termination after they concluded that the combo failed to show any benefit over Tecentriq alone in a mid-stage trial. On top of this, the committee found that there were increases in mortality-related events in the combination arm when compared to the placebo. In light of these events, Janssen have also committed to terminating a phase 1 trial (MMY2036) investigating daratumumab and the anti PD-1 antibody JNJ-63723283 in multiple myeloma. Please click here for more from PharmaTimes.



Max Lymbery

Date Published

01st June 2018

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