Regulatory Index News: 15/05/2018

Welcome to your Regulatory Index News update today. Whilst one drug maker gains an approval, one receives a delay, and another makes a discovery. Read here to keep up to date.

​Novartis' Gilenya gets FDA pediatric approval

Children and adolescents with relapsing forms of multiple sclerosis (RMS) will soon be offered Novartis' Gilenya (fingolimid) treatment since US regulators’ approval in this indication.  The president of Pediatric Multiple Sclerosis Alliance, Elin Phillips, said "We have eagerly anticipated a proven treatment option for younger people living with MS [and] until now, there have been no large clinical trials to assess treatment efficacy of disease-modifying therapies in children and adolescents". The drug, previously only approved for adult patients, is the first disease-modifying therapy indicated for individuals aged between 10 and 18. Last Friday's approval comes after a phase 3 clinical trial in patients in this age group showed Gilenya reduced annualised relapse rates by approximately 82% over two years compared with interferon beta-1a injections. Please click here to read more from a PharmaTimes article.



Puma shares plummet as results from key trial delayed 

A delay in the reporting of its data from a key study of its cancer drug Nerlynx being tested in third-line HER2-positive metastatic breast cancer, sparked a sell-off in Puma's shares last Thursday. Results were previously anticipated to be released in late June but due to the event rate in the study being slower than expected, these are now pushed back until 4th Quarter 2018 at the earliest. Data release could potentially be delayed even further until 2019 if event rate or confirmed data on patient’s progression-free survival slowed further.  On Thursday 11th May 2018, Puma shares closed at 21% the lowest level since around summer of 2017.  Please click here to read more from a BioPharmaDive article



​Discovery of mutation-caused PARP inhibitor resistance

A team at the Institute of Cancer Research in London (ICR) identified a specific mutation in the PARP1 protein that stops PARP inhibitors, such as AstraZeneca’s Lynparza from working. A leading Professor of Cancer Genomics at The ICR, Professor Chris Lord noted that “the evolution of cancers into drug resistant forms is a major challenge we face in getting cancer treatments to work.”  Baroness Delyth Morgan, CEO at Breast Cancer Now had this to say “studies like this, which build on the development of PARP inhibitors as a brand new treatment option for some women with breast cancer, could help take us a step closer to an even more personalised approach to treating the disease.”  Please click here to read more from a PharmaTimes article.





Lorna Osborn

Date Published

15th May 2018

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