What’s been authorised? UK, Europe, US drug approvals

People sitting around a desk with laptops and tablets to show Pharma drug approvals round-up: UK, Europe, US

Pf summarises the UK, Europe and US drug approvals from 20 – 24 Jan 2020.

UK

The National Institute for Health and Care Excellence published draft guidance which does not recommend ustekinumab (Janssen’s STELARA®) for treating moderately to severely active ulcerative colitis in adults.

Both the All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC) published their positive recommendation that Regeneron and Sanofi’s dupilumab can be used for restricted use the treatment of adolescent patients (≥ 12 to < 18 years of age) with moderate to severe atopic dermatitis who are candidates for systemic therapy, only if the disease has not responded to at least one other systemic therapy or these are contraindicated or not tolerated.

NICE has issued draft guidance not recommending Liraglutide (Novo Nordisk’s Saxenda) within its marketing authorisation, for managing overweight and obesity in adults alongside a reduced-calorie diet and increased physical activity.

The European Commission has granted conditional marketing authorisation for Roche’s Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma who are not candidates for a haematopoietic stem cell transplant.

Europe

The European Medicines Agency (EMA) has granted a licence for the use of Novartis’ Mayzent® (siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.

European Commission approves Janssen’s Darzalex® (daratumumab) in combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for patients with newly diagnosed multiple myeloma who are transplant eligible.

Jazz Pharmaceuticals plc receives the European Commission approval for Sunosi® (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

The European Commission has approved the expanded use of Janssen’s STELARA® (ustekinumab) for the treatment of paediatric patients (ages 6 to 11) with moderate to severe plaque psoriasis.

USA

GlaxoSmithKline announced that the US Food and Drug Administration granted a priority review for the company’s Biologics License Application seeking approval of belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

The National Institute for Health and Care Excellence (NICE) has published final guidance that does not recommend AstraZeneca’s Tagrisso▼ (osimertinib) for use within NHS England, in line with its licensed indication, for untreated locally-advanced or metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer in adults.

AstraZeneca and MSD announced that a supplemental New Drug Application for Lynparza (olaparib) has been accepted and granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, who have progressed following prior treatment with a new hormonal agent.

AstraZeneca’s Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation in the US for the treatment of hepatocellular carcinoma, the most common type of liver cancer.