Regulatory Index News: 15/02/2018

Welcome to your Regulatory Index News update today. Several big approvals have been awarded across the US and EU, take a read here for the breakdown.

FDA awards first-of-its-kind approval for J&J’s prostate cancer drug

Cancer drugs are generally approved based on life-extending or disease halting ability, however, the approval of J&J’s Erleada was based upon its ability to prevent cancer spreading to other parts of the body (metastasis-free survival). This is the first-ever example of this type of approval leaving Erleada with an indication in non-metastatic castration-resistant prostate cancer. This comes less than two weeks post-announcement of J&J’s positive topline results from an Erleada Phase 3 trial, which showed that it delayed development of metastases by more than two years. This leaves J&J as a greater dominating force in the prostate cancer therapeutic area, with their other prostate cancer drug Zytiga. Please click here to read more from a BioPharmaDIVE article.

Novo’s once-weekly diabetes therapy gains EU approval

Ozempic, Novo Nordisk’s once-weekly diabetes therapy, has now been approved as a monotherapy to treat adults with type II diabetes when metformin is considered inappropriate, and as an addition to other medicinal treatments to improve glycaemic control. This treatment works by inducing the glucagon-like peptide-1 (GLP-1) receptor, leading to statistically significant decreases in glycated haemoglobin (HbA1c) compared to placebo and other treatments. The drug was also found to statistically significantly reduce patient body weight in a clinical trial (SUSTAIN). This now leaves the drug approved in the US (December 2017) and Europe, with an expected EU launch in the second half of 2018. If you would like to read more on this, click here for a PharmaTimes article.

US approval for Vertex’ cystic fibrosis combination treatment

The FDA have approved the cystic fibrosis combination treatment known as Symdeko, which is a combination of Kalydeco and tezacaftor, to treat cystic fibrosis patients which have two copies of the F508del mutation or one mutation that is responsive to the treatment. The key clinical data leading to the approval was from two different Phase 3 trials, where the treatment was generally well-tolerated. One trial (EVOLVE) studied the treatment in patients with two F508del mutations over 24 weeks which showed a mean absolute improvement in ppFEV1, a measure of lung function. The other (EXPAND), studied the combination in patients with one F508del mutation and residual CFTR function and also found an absolute change in ppFEV1 at week 4 and week 8. The treatment is now under review in the EU. Please click here for further details from a PharmaTimes article. 



Max Lymbery

Date Published

15th February 2018

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