PRESS RELEASE Italfarmaco partners with Iktos on artificial intelligence to speed drug discovery breakthroughs for patients Combines AI to increase the potential of novel histone deacetylase (HDAC)...
SILVER SPRING, Md., March 21, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.
Results from Italfarmaco Pivotal Phase 3 EPIDYS Study of Givinostat in Duchenne Muscular Dystrophy (DMD) Published in The Lancet Neurology
Nerviano and Italfarmaco Announce Licensing of Linker-Payload Technology
Italfarmaco Group Receives EMA Validation of Marketing Authorization Application for Givinostat in Duchenne Muscular Dystrophy
MILAN--(BUSINESS WIRE)--Italfarmaco, an Italian multinational company in the chemical-pharmaceutical sector, has acquired 100% of Lacer Pharmaceuticals, one of the leading companies in Spain in the area of health and personal hygiene.
MILAN--(BUSINESS WIRE)--Italfarmaco Group announced today positive topline data from its completed Phase 3 EPIDYS trial with Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor, in boys with Duchenne Muscular Dystrophy (DMD). The primary objective of the study was to evaluate the effects of Givinostat on slowing disease progression in ambulant DMD boys aged 6 years and above on chronic steroids. The study compared Givinostat to placebo and met the primary endpoint (change from baseline in the time to climb 4 stairs) following 18 months of treatment in the target population1 with key secondary endpoints consistent with the functional primary endpoint. Givinostat continued to demonstrate a tolerability profile in line with previous studies. The topline data were presented by Italfarmaco Group’s Chief Medical Officer, Dr. Paolo Bettica on June 25, 2022, at the hybrid Parent Project Muscular Dystrophy (PPMD) Annual Conference.
Italfarmaco Group announced today topline data from its proof-of-concept Phase 2 trial with Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor, in 51 adult males with Becker Muscular Dystrophy (BMD). The study was designed to evaluate the effect of Givinostat in BMD, building on the experience developed in Duchenne Muscular Dystrophy.
MILAN--(BUSINESS WIRE)--The Italfarmaco Group announced a publication in the Blood Cancer Journal outlining the first interim analysis results from follow-up of a mean of four years in 51 patients with polycythemia vera (PV), a type of hematological malignancy belonging to BCR-ABL1-negative chronic myeloproliferative neoplasms (MPNs). The results show a long-term benefit in PV patients treated with givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor. The publication covers the overall long-term data from patients that were a part of three Phase 1/2 studies, as well as from a compassionate use program. The data preliminarily support the long-term use of givinostat. The open access article is available via this link.
MILAN & BASEL, Switzerland--(BUSINESS WIRE)-- Italfarmaco Group (Italfarmaco) and Luye Pharma Switzerland AG (“Luye Switzerland”), a fully owned subsidiary of Luye Pharma Group (Luye Pharma) announced today that they have entered into an agreement under which Italfarmaco receives exclusive rights to commercialize Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) in four European countries. Rivastigmine MD, developed by Luye Pharma, is used to treat mild to moderate dementia associated with Alzheimer's disease and is currently in the final registration phase of marketing approval in Europe. This product represents an important strategic addition to Italfarmaco’s central nervous system (CNS) portfolio, building on its depth of knowledge in this therapeutic area.