Regulatory Index News: 18/12/2017

Welcome to your Regulatory News digest this Monday. Take a read here for all your pharmaceutical news.

GSK’s Nucala gains a new US approval, granting new market access

AZ’s Fasenra and Teva’s Cinqair have recently been approved for severe eosinophilic asthma forcing GSK’s Nucala to compete in a once uncrowded market. However, Nucala has newly received an FDA approval for treatment of eosinophilic granulomatosis with polyangiitis (EGPA) caused by inflammation in the walls of blood vessels. This is the first-ever targeted therapy approved for this chronic rare disease which affects around 5,000 patients in the US and will allow the reduced use of corticosteroids to suppress the inflammation. GSK have however not stopped there, as they have applied for an indication in COPD and are currently trialing in other areas such as nasal polyps. If this interests you, please click here for an article from FiercePharma.

FDA approval for Pfizer’s Xeljanz in psoriatic arthritis

The US regulators have cleared the treatment for adults with active psoriatic arthritis (PsA) who are either not respondent or intolerant to other disease-modifying antirheumatic drugs (DMARDs). This marks Xeljanz as the first Janus kinase (JAK) inhibitor FDA approved for treatment of both moderate to severe rheumatoid arthritis (RA) and active PsA. The approval was based on data from two Phase III trials, OPAL Broaden and OPAL Beyond, which both hit their primary efficacy targets to significantly improve patients American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score. The trials also showed a comparable safety profile to when used in RA. Please click here if you would like to read more on this story from a PharmaTimes article.

NICE recommendation for Janssen’s Imbruvica

The UK cost assessors have deemed that Imbruvica is cost effective for patients with mantle cell lymphoma (MCL) that have only had one prior line of therapy. This comes after a previous conclusion to not recommend the treatment for all MCL patients as it did not offer cost-effective NHS value. Whilst the treatment is currently available on the Cancer Drugs Fund (CDF) for those where their disease has returned or they have proven non-respondent to first-line treatment, it is now being recommended for use in routine channels as a second-line treatment. This decision is largely due to Imbruvica being considered within the ‘end-of-life’ threshold and that its costs less than £49,848 per QALY gained. If you would like to know more, please click here for a PharmaTimes article. 



Max Lymbery

Date Published

18th December 2017

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