Regulatory Index News: 27/03/2018

Welcome to your Regulatory Index News update today. Take a read here to learn of three new and interesting EU approvals.

EU and Japanese approval for GSK’s Shingrix

GSK has received confirmation of a Shingrix approval from the regulators in Europe and Japan, adding to the previous approvals in US and Canada. The vaccine is used to treat Shingles, where various studies have shown that it last four years and offers stronger protection than the older Zostavax from Merck. This comes as good news to the population of Europe and Japan, with around 1 in 3 affected by Shingles. Analysts now predict that Shingrix will reach the blockbuster status with sales of $1.368 billion by 2022. Zostavax sales have already declined with a 45% drop in the fourth quarter to $121 million and are expected to fall further. If you would like to read more, please click here for a FiercePharma article.

TiGenix and Takeda’s gain first-ever allogeneic stem cell therapy EU approval

Alofisel has been cleared as the first allogeneic (donor derived) stem cell (expanded adipose-derived) therapy to be approved across the EU. The treatment is to be locally administered to treat complex perianal fistulas in adult patients with nonactive/mildly active luminal Crohn’s disease, after an inadequate response in fistulas to one or more conventional or biologic therapy. Perianal fistulas are a common problem with Crohn’s disease which may lead to incontinence and sepsis and when rarely complex, are more treatment resistant. The approval was based upon clinical data which showed a 44% increase in combined remission compared to placebo. Please click here if you would like to read further from a PharmaTimes article.

EU nod for new hyperkalaemia treatment from AZ

AstraZeneca’s Lokelma is an insoluble, non-absorbed compound which has now been EU approved to treat hyperkalaemia by preferentially capturing potassium ions. Hyperkalaemia is a condition which leads to elevated potassium levels in the blood. The risk of developing it is far higher in patients with chronic kidney disease and those which take common medication for heart failure such as renin-angiotensin-aldosterone system (RAAS) inhibitors. This approval is based upon clinical data which showed that Lokelma restored normal potassium levels after a median time of 2.2 hours and 98% of patients achieved normal levels within 48 hours. Lokelma is still under review in the US. Please click here for more on this from a PharmaTimes article.



Max Lymbery

Date Published

27th March 2018

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