Regulatory Index News: 26/12/2017

Welcome to your Regulatory Index News digest today. We hope you all had an enjoyable festive break. Please take a read here for your Pharmaceutical news refresher.

La Jolla’s Giapreza wins FDA's 46th nod of the year

Giapreza may have gained the final US approval for this year, for treatment of adult patients with dangerously low blood pressure. One analyst wrote that the medicine has won a “relatively broad label” which compares favorably to Endo's Vasostrict and it is likely to come out as a third-line treatment. La Jolla is set for their first-ever launch of the drug in March 2018, with the sales force deployed in January, and is expected to generate half a billion dollars in the US at its peak. This marks the 46th FDA approval of 2017 which surpasses the record of 45 in 2015 and greatly eclipses last year’s 22 approvals. If you would like to read more on this approval, please click here for a FiercePharma article.

Janssen to collaborate with Legend Biotech on experimental CAR-T therapy

Janssen have entered a global agreement with Legend Biotech USA and Legend Biotech Ireland to develop, manufacture and commercialise LCAR-B38M. This is an experimental CAR-T cell therapy which specifically targets a B-cell maturation antigen (BCMA), commonly expressed on myeloma cells. It is currently under review by the Chinese regulators and in the planning phase of clinical studies in the US for multiple myeloma. In this collaboration deal, Janssen has paid an upfront cost of $350 million for the global license to jointly develop and commercialise, and will also make additional payments based upon the drugs achievements in development, regulatory and sales milestones. Please click here to read further into this story in an article from PharmaTimes.

Roche’s Tecentriq rejected by NICE for pre-treated urothelial cancer

NICE, the UK’s cost assessors, have turned down Tecentriq for patients which have already received prior treatment for metastatic urothelial cancer. They deemed from two clinical trials that the treatment is an effective therapy when compared with the treatment options for patients whose disease has progressed after platinum-based chemotherapy however, the cost was found to be very high relative to the benefit provided and there were reservations with the long term economic model. Whilst Tecentriq meets NICE criteria to be a life-extending treatment, the list price incremental cost effectiveness ratio was £100,844 per quality-adjusted life year (QALY) gained compared with the taxanes, and thus found not to be cost effective, so is not being recommended for the Cancer Drugs Fund (CDF). Please click here to read more from a PharmaTimes article. 



Max Lymbery

Date Published

26th December 2017

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