It is also available in Italy Ozanimod, oral drug indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease. L’Italian Medicines Agency (AIFA) approved the reimbursement of Celgene therapy, part of Bristol-Myers Squibb, according to the criteria expressed in the Official Gazette No. 213, of 6 September 2021. The new therapeutic option is presented today in an online press conference.
“Multiple sclerosis is one of the most frequent neurological pathologies in young adults and most widespread all over the world, in particular the relapsing-remitting form represents about 85% of all cases of the disease – underlines prof. Gioacchino Tedeschi, President of SIN – Italian Society of Neurology -. This form is distinguished by the alternation of phases, of unpredictable duration, characterized by the onset of sudden neurological deficits and phases of complete or partial remission. A fluctuating situation that can compromise the quality of life of patients. It is estimated that every year in our country alone 3,600 people are affected by multiple sclerosis, with a prevalence of about 130,000 cases. Furthermore, a percentage of patients have a cognitive deficit. New opportunities are opening up for these sick people today ”. Ozanimod works by modulating the immune response by interacting with the receptors of Sphingosine 1-Phosphate. In particular, it acts on isotypes 1 and 5, the most involved in the modulation of the immune response and in the repair of myelin damage. Its peculiarity is that by acting selectively it guarantees a good balance between efficacy and safety. The therapy is administered orally once a day and has been shown, in pivotal clinical studies, to reduce the volume loss of both cortical and thalamic gray matter, slowing down the deterioration of related cognitive faculties. It also reduces the number of demyelinating lesions on MRI, both inflammatory and total, indicating the reduced progression of the disease. “It is great news for people to have effective new drugs, including oral ones, for a disease such as multiple sclerosis – he continues Mario Alberto Battaglia, President of the IMF – Italian Multiple Sclerosis Foundation and General Director of AISM – Italian Multiple Sclerosis Association -. It allows you to have an ever better personalized medicine. Today, early therapy means not only preventing new attacks but also slowing down and blocking the progression towards disability, but it must above all be a personalized therapy for the form of the disease, for the characteristics and for the evolution without forgetting the needs of quality of life. Multiple sclerosis today at diagnosis means young people, mostly women, who want to be able to lead an active working and social life in the future. Treating well means not reaching disability, reducing the high social cost and guaranteeing years of quality of life for those who face the challenge of this chronic disease every day ”.
Multiple sclerosis reduces life expectancy from 7 to 14 years compared to the general population. It is also linked to an increased risk of mortality from other serious diseases. It is a disease in which the immune system attacks myelin, the protective sheath that covers the nerve fibers. This creates “an interruption of the electrical signal” by altering the communication between the central nervous system and the rest of the body. It affects about 130 thousand patients in Italy (for a total of 1 million and 200 thousand cases in Europe and 2.8 million worldwide). “It is essential to be able to expand our therapeutic armamentarium with new treatments such as Ozanimod capable of limiting flare-ups of the disease, improving the prognosis” continues prof. Germans. “We are proud to be able to offer Italian patients an extremely effective and well tolerated therapy – concludes Dr. Cosimo Paga, Executive Medical Director Bristol-Myers Squibb Italy -. Ozanimod is part of our rich pipeline in immunology. Italy can boast a network of centers of absolute excellence for the treatment and assistance of patients affected by multiple sclerosis. Now a further treatment is available that will improve the quality of life of thousands of patients ”.