Pharma appraisals, approvals and launches

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Pf’s weekly summary of pharma appraisals, approvals and launches, including NICE recommendation of avatrombopag and the FDA’s approval of Sanofi’s Sarclisa® in combination.

UK

The National Institute for Health and Care Excellence has published final draft guidance recommending avatrombopag (Dova Pharmaceuticals) for treating thrombocytopenia (low platelet count) in people with chronic liver disease needing surgery.

Celltrion Healthcare announced the UK launch of Remsima® SC (infliximab), the first and only subcutaneous formulation of infliximab for the treatment of patients with rheumatoid arthritis. The UK launch follows European Commission approval of Remsima® SC for patients with rheumatoid arthritis in November 2019

Europe

Shionogi announced that the CHMP of the European Medicines Agency issued a positive opinion recommending the approval of FETCROJA® (cefiderocol), a new antibiotic for the treatment of infections due to aerobic Gram-negative bacteria in adult patients (18 years or older) with limited treatment options.

Almirall announced that the European Medicines Agency has accepted the filing of the Marketing Authorization Application for tirbanibulin, also known as ALM14789, for the treatment of actinic keratosis.

Abbott announced it has received CE Mark for the new FlexNav™ delivery system for the company’s Portico™ transcatheter aortic valve implantation (TAVI) system, enabling marketing authorization in Europe.

Clovis Oncology announced that Rubraca® (rucaparib) is now available and reimbursed in Spain following the Spanish Interministerial Commission on Prices of Medicines and Health Products approval. Rucaparib is now available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.

Primex Pharmaceuticals has received international approval of the repeat use procedure for OZALIN® (ADV6209) involving the following eight countries: Germany, Austria, Spain, Portugal, Ireland, Belgium, Greece, and Poland.

USA

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Sarclisa® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the US shortly.

Biocomposites announced the US launch of STIMULAN® Rapid Cure 3cc. Designed specifically for smaller voids in foot and ankle, orthopaedic reconstruction and trauma procedures, this new addition expands the company’s US product portfolio for use in the presence of infection.


Find out what else has been approved this year?