Pharma marketing authorisations, approvals and appraisals

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Pf rounds up this week’s pharma marketing authorisations, approvals and appraisals, featuring news from the UK, EU, Japan and the USA.

UK

Kyowa Kirin International announced that the SMC has enabled access to Crysvita® (burosumab) in the NHS in Scotland to treat X-linked hypophosphataemia (XLH), in children with radiographic evidence of bone disease, one year of age and older and adolescents with growing skeletons.

Europe

Pfizer Ltd announced that the European Commission has granted marketing authorisation for VYNDAQEL® (tafamidis), a once-daily 61mg oral capsule, for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.

Novartis announced the European Commission has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration. Beovu is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a key marker of disease activity, versus aflibercept (secondary endpoints).

Japan

Bristol-Myers Squibb Company announced Japan’s Ministry of Health, Labor and Welfare has approved Opdivo (nivolumab) for the treatment of patients with unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy.

USA

Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq® (atezolizumab) as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type), as determined by PD-L1 biomarker testing.

MSD announced that the FDA has issued a Complete Response Letter regarding MSD’s supplemental Biologics License Applications seeking to update the dosing frequency for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, to include a 400 mg dose infused over 30 minutes every-six-weeks (Q6W) option in multiple indications.


Previous approvals and appraisals

Pf’s weekly drug approvals and appraisals – 14 February 2020

Pharma roundup: drug approvals and appraisals – 7 February 2020

Latest pharma drug approvals and appraisals – 31 January 2020

What’s been authorised? UK, Europe, US drug approvals – 24 January 2020