FDA approves Gamifant for ultra-rare illness
Sobi, an international biopharmaceutical company dedicated to rare diseases, and Novimmune, a Swiss biotech company, have received the green light from the Food and Drug Administration for Gamifan (emapalumab-lzsg), an interferon gamma, blocking antibody for the treatment of pediatric — newborn and older — and adult patients with primary hemophagocytic lymphohistiocytosis, or HLH, with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.
Primary HLH is an ultra-rare syndrome of hyper-inflammation with high morbidity and mortality, and for which there was previously no approved drug. Gamifant represents a major advance in the treatment of these patients through a targeted mode of action.
“Today’s landmark approval of Gamifant will allow Sobi to bring the first and only FDA-approved treatment for primary HLH to a rare disease community that has faced high mortality without much improvement in care for the past 24 years,” Sobi North America president Rami Levin said.
Gamifant is expected to be available for administration in treatment centers in the first quarter of 2019.
MinuteClinic gets Joint Commission’s Gold Seal of Approval for ambulatory care
MinuteClinic, the retail medical clinic of CVS Health, has received its fifth consecutive accreditation by The Joint Commission — the Gold Seal of Approval for Ambulatory Health Care Accreditation, demonstrating continuous compliance with its nationally recognized standards.
MinuteClinic was the first national retail clinic provider to be accredited by the Joint Commission, receiving its initial accreditation in 2006. Since then, it has received four consecutive reaccreditations from the national healthcare evaluation and certifying agency.
The Joint Commission’s gold seal of pproval denotes MinuteClinic’s compliance with the organization’s national standards for ambulatory healthcare quality and safety, the company said. Valid for up to a three-year period, the Joint Commission accreditation applies to MinuteClinic’s 1,100 locations inside select CVS Pharmacy and Target stores in 33 states and the District of Columbia.
“MinuteClinic is incredibly proud to have again received The Joint Commission’s Gold Seal of Approval. This reaccreditation validates that we are delivering on our commitment to provide high quality clinical care and to follow rigorous safety standards at all MinuteClinic locations across the country,” MinuteClinic executive director and CVS Health senior vice president Sharon Vitti said. “With patient satisfaction ratings of 95% and clinical collaborations with more than 70 leading health systems throughout the country, we continue to demonstrate a consistent record of high quality, coordinated care.”
Glenmark gets FDA nod for generic Finacea gel
Glenmark Pharmaceuticals has received the Food and Drug Administration’s approval for for azelaic acid gel 15%.
The product is the generic version of Leo Pharma’s Finacea gel 15%.
It is indicated for topical treatment of the inflammatory papules and pustules of mild-to-moderate rosacea.
Finacea gel,15% had a market value of about $64.1 million for the period ending September 2018, according to IQVIA.