Regulatory Index News: 06/02/2018

Welcome to your Regulatory Index News update today. Trial results, a black box warning and NICE approvals make for interesting reading.

Eisai and Bial’s epilepsy treatment found non-inferior to current standard of care

Zenibix has been shown to have an effectiveness on par with the current standard of care in newly diagnosed focal epilepsy patients. The once-daily monotherapy was tested in a Phase 3 trial against the standard of care twice-daily controlled-release carbamazepine, which showed that the monotherapy as non-inferior. In this trial, 71.1% of patients on Zenibix and 75.6% of those on controlled-release carbamazepine were seizure free for at least 6 months (64.7% and 70.3% respectively for one-year data). Another finding was that whilst the adverse event profile was similar between the two treatments, Zenibix actually had a lower rate of discontinuation due to adverse events. With approximately 50 million people affected by epilepsy in Europe, these results clarify possible alternatives to standard of care which may provide improved treatment tailoring. Please click here to read further from a PharmaTimes article.

Black box warning for Intercept's Ocaliva

The FDA have stated that they will be adding a black box warning to the label of Ocaliva, which treats chronic liver disease, to caution against overdosing in higher-risk patients and recommending closer monitoring. This is Intercept’s only marketed product, approved back in April 2016, to treat a rare type of chronic liver disease known as primary biliary cholangitis. The drug was forecast for blockbuster sales due to its potential in other diseases but there have been safety concerns with the drug when administered in higher-than intended doses. Whilst this warning would usually cause a negative effect with investors, shares of Intercept increased by over 10% on market open which is likely due to the fact that the FDA did not more broadly limit its use. If you would like to read more, please click here for a BioPharmaDIVE article.

Two new NICE approvals secured for routine NHS treatment

The National Institute for Health and Care Excellence (NICE) have awarded two new approvals for routine NHS use of a mantle cell lymphoma (MCL) treatment and breast cancer treatment. Janssen’s Imbruvica is one of these, and will be now routinely available on the NHS to treat MCL in patients which have had one prior line of therapy. This second-line designation comes after the previous evaluation that Imbruvica is not cost-effective for the NHS as a first-line therapy. Roche’s Perjeta is the other which has now received a final green light, to move from the Cancer Drugs Fund (CDF) and into NHS routine treatment of HER2-positive breast cancer. This has been deemed to offer new hope of how the treatment will be funded in the longer term and ensures patients will have continued access. Please click here to read more on Imbruvica and here to read more on Perjeta. 



Max Lymbery

Date Published

06th February 2018

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