Regulatory Index News: 27/11/2017

Welcome to your Regulatory News update this Monday. Here are a few of the interesting stories which are occurring in the industry today.

UK launch for Tremfya, Janssen’s new psoriasis biologic

Janssen have announced their UK launch of Tremfya for adult patients with moderate to severe plaque psoriasis. This biologic has been approved by the EU regulators to treat psoriasis that selectively blocks a cytokine, interleukin (IL)-23, which is key in initiating a specific immune inflammatory response in patients with the condition. This is great news for those in the UK, with the disease affecting around three percent of the population which is an estimated 1.8 million people. After the key VOYAGE 1 and 2 trials, it is clear that this product is efficacious whilst the company states that the product presents no clear signals of increased risk of malignancy, major cardiovascular events or serious infections such as tuberculosis. If you would like to read more on this story, please click here for a PharmaTimes article.

NHS to stop funding of Roche’s Erivedge after NICE guidance

Erivedge was previously approved for NHS reimbursement in 2013 to treat advanced basal cell carcinoma (BCC) in patients unable to receive surgery or radiotherapy. However, NICE, the UK’s reimbursement assessors, have recently issued final guidance that Roche’s skin cancer drug is no longer cost effective and concluded that clinical benefit was unclear. These conclusions arose as little clinical data was collected for overall survivability with BCC and no trials had directly compared the drug and the best supportive care where there are large economic differences. This means that the drug will now be removed from the Cancer Drugs Fund (CDF) and the NHS will cease its use. Please click here if you would like to read further in an article from PharmaTimes.

FDA issue final guidance to accelerate abuse-deterrent opioid generic development

Opioid abuse has been a huge problem in the US with over 183,000 US deaths due to opioid overdose between 1999 and 2015. This is why the FDA are pushing for more abuse-deterrent opioid generics for pain-management by making it easier to bring them through development and into the market. They have issued new guidance on how opioid manufacturers can best show how their generic is just as difficult to exploit as innovator product. One suggestion on how they can achieve this was through using a tier-based system that evaluates drug safety on the basis of measures the patient would have to go through to exploit it. If you would like to read more, click here for an article from BioPharmaDIVE.

M L

Author

Max Lymbery

Date Published

27th November 2017

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