Regulatory Index News: 04/07/2018

Welcome to your Regulatory Index News digest this Wednesday. Including a NICE denial, positive Phase 3 study results in breast cancer and a commercialisation deal for an EpiPen rival.

Swiss company Roche unveil positive data in Phase 3 breast cancer trial

Roche's IMpassion130 study, which combines Tecentriq (atezolizumab) with Abraxane, showed significant reduction in the risk of disease worsening or death in some breast cancer patients. According to Roche, this is the first Phase 3 immunotherapy study to show a statistically significant improvement in progression-free survival (PFS) in the intention-to-treat and PD-L1 positive first-line metastatic triple negative breast cancer populations. Tecentriq is already approved in several countries for people with previously treated metastatic non-small cell lung cancer (NSCLC) and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). An “encouraging” overall survival benefit for PD-L1 positive population at interim analysis was also observed. Please click here to read more on this from a PharmaTimes article.


Mylan's EpiPen franchise under threat by epinephrine autoinjector competitor deal

Mylan's launch of an authorized generic version of their EpiPen, following pushback over pricing, alongside other competition has affected their sales. Added to this is the public relations battles following criticism of overcharging for a pair of their auto-injectors and a $465 million settlement payment for a False Claims Act suit related to EpiPen pricing.  And now, Adamis Pharmaceuticals has agreed a deal with Novartis's generics unit, Sandoz to commercialise its epinephrine autoinjector in the US. At the time of the Symjepi launch, analysts speculated the product could be a major threat to EpiPen because of its easier usage.  Please click here to read more on this from a BioPharmaDive article.

No NHS funding for Roche’s Ocrevus for treatment of primary progressive multiple sclerosis in adults

In draft guidelines The National Institute for Health and Care Excellence (NICE) agreed that Roche's Ocrevus (ocrelizumab) is a “step change” in treatment for primary progressive multiple sclerosis (PPMS). However, it said it had not seen evidence of any additional benefits not captured in its cost-effectiveness assessment, and therefore did not recommend it for funding on the NHS for treatment of PPMS. This condition affects around 14 percent of MS patients at the time of diagnosis and clinical results show that Ocrevus can slow the worsening of disability in people with the condition, but the drug’s cost per QALY compared with best supportive care was estimated to be higher than what is normally considered value for money for the NHS. Please click here to read more on this from a PharmaTimes article.



Lorna Osborn

Date Published

04th July 2018

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