Regulatory Index News: 21/12/2017

Welcome to your Regulatory Index News update for today. Please take a read for the current stories in pharmaceuticals.

Spark’s gene therapy drug for blindness gains US approval

The FDA have approved the Spark Therapeutics’ Luxturna for use in patients with a hereditary form of vision loss, known as rare retinal dystrophy, which marks the first-ever gene therapy commercially cleared for treatment of an inherited disease. The drug works by introducing a functional copy of the gene, RPE65, to restore the visual ability of the patient. It is expected that this condition affects around 1000-2000 patients in the US so will bring great aid when available in first-quarter of the new year. This approval represents the acceleration of the field of gene therapy, but it is still unknown how the advancements and huge prices which come with them will test the healthcare system’s ability to pay for them. If you would like to read further into this, please click here for an article from BioPharmaDIVE.

FDA approval for Merck and Pfizer’s joint venture, Steglatro

A new diabetes drug has been approved as the fourth-to-market SGLT2 drug which is expected to role out in January. It has been approved individually as well as in combination as Steglujan where it is combined with Merck’s stalwart diabetes drug, Januvia and as Segluromet, a metformin-Steglaro duo. However, as the fourth-to-market, Steglatro will have stiff competition with the well-established rivals but Merck and Pfizer are hoping the combination with Januvia may help win over some market share and pricing will play a part. The approval was based on a range of clinical data that included one head-to-head combo test against Januvia itself. Please click here if you would like to read more from a FiercePharma article.

Double win for Roche with a new EU and US approval

Roche have gained an EU approval for Alecesna, for first-line treatment of patients with ALK-positive non-small cell lung cancer (NSCLC), which means there is a new option for newly diagnosed  patients. The approval was based upon a Phase III ALEX study which showed the drug significantly reduced the risk of the disease worsening or death by 53% compared to crizotinib. Roche group Genentech have also gained an approval in the US for Perjeta in combination with Herceptin and chemotherapy for adjuvant treatment of a HER-2 positive early breast cancer at high risk of reoccurrence. This approval was based on a Phase III APHINITY study which showed the regimen significantly reduced the risk of invasive breast cancer reoccurrence or death by 18% compared to Herceptin and chemotherapy alone. For more from PharmaTimes articles on Alecesna, please click here, and for more on Perjeta, please click here.  



Max Lymbery

Date Published

21st December 2017

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