Daily Top News – June 26, 2020

June 26, 2020

Reblozyl (luspatercept-aamt) / Acceleron, BMS
European Commission Approves Reblozyl (luspatercept) for the Treatment of Transfusion-Dependent Anemia in Adult Patients with Myelodysplastic Syndromes or Beta Thalassemia (Businesswire) – Jun 26, 2020 – “Bristol Myers Squibb…and Acceleron Pharma Inc…announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of…Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy….This approval is based on data from the pivotal Phase 3 MEDALIST and BELIEVE studies, evaluating the ability of Reblozyl to effectively address anemia associated with MDS and beta thalassemia, respectively.”

 

casimersen (SRP-4045) / Sarepta Therap
Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Casimersen (SRP-4045) for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45 (Sarepta Therap Press Release) – Jun 26, 2020 – “Sarepta Therapeutics…today announced the Company has completed the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for casimersen (SRP-4045)….The completion of the rolling submission includes data from the casimersen arm of the ESSENCE study (also known as study 4045-301)…Phase 3 study evaluating efficacy and safety in patients amenable to skipping exons 45 and 53…If the casimersen NDA is accepted and granted accelerated approval, the completed ESSENCE study will serve as a post-marketing confirmatory study.”

 

 

Cosentyx (secukinumab) / Novartis
Novartis Cosentyx gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile (Novartis Press Release) – Jun 26, 2020 – “Novartis…today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to

 

Kalydeco (ivacaftor) / Vertex; Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex
CHMP Grants Positive Opinion for KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in Combination With KALYDECO (ivacaftor) in People Ages 12 and Older With Cystic Fibrosis With the Most Common Genotypes (Businesswire) – Jun 26, 2020 – “Vertex Pharmaceuticals…today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with KALYDECO® (ivacaftor) 150 mg to treat people with cystic fibrosis (CF) ages 12 and older with one F508del mutation and one minimal function mutation (F/MF) or two F508del mutations (F/F) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene….The CHMP positive opinion was based on the results of two global Phase 3 studies in people with CF…”

 

COSMO RECEIVES POSITIVE EMA CHMP OPINION RECOMMENDING APPROVAL OF METHYLENE BLUE MMX FOR THE VISUALIZATION OF COLORECTAL LESIONS DURING COLONOSCOPIES (Cosmo Press Release) – Jun 26, 2020 – “Cosmo Pharmaceuticals…today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Methilthioninium Chloride Cosmo (Methylene Blue MMX), its drug for the visualization of colorectal lesions during colonoscopies…The final decision on the Marketing Authorisation Application for Methylene Blue MMX is expected in the next couple of months…”

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