New subcutaneous formulation for vedolizumab monoclonal antibody, biotechnological drug with intestinal selectivity, already available in intravenous formulation for the treatment of adult patients with moderate to severe ulcerative colitis or active Crohn’s disease. There new method of administration in syringe or pre-filled pen, recently authorized by the Italian drug agency Aifa, represents “a turning point – Takeda announces – for all patients who were used to having to go to the hospital of reference for the infusion”, and who will now be able to “receive treatment directly at home or in a doctor’s office“, or also “self-administer the drug after adequate training by the reference specialist “.
At least 200 thousand people in Italy are affected by Mici, chronic intestinal inflammatory diseases just like ulcerative colitis or Crohn’s. Often invisible to others – a note recalls – these pathologies have a devastating impact on the quality of life of those who suffer from them. The onset can take place between the ages of 20 and 30, in the midst of social and work activity, in a similar percentage in men and women. “The advantages linked to the new method of administering this drug – Takeda points out – concern the entire health system. From an organizational and economic point of view, the possibility of receiving treatment directly at home or in the doctor’s office allows hospitals to free resources in the departments, contributing to a clear reduction in healthcare costs “.
“The events of the last year and a half, linked to Covid-19, have stimulated many doctors and patients to turn, as far as possible, from assistance in the presence to telemedicine techniques for the management of chronic intestinal inflammatory diseases, moving from hospital at the patient’s home – he says Marco Daperno, gastroenterologist and general secretary of the Ig-Ibd scientific society – The possibility of using the intravenous route for treatment for the shortest time necessary, followed by a maintenance regimen with subcutaneous treatment comfortably at home, represents an important innovation that fits precisely into this therapeutic trend “.
“The new subcutaneous formulation can also have a positive impact on hospitals, freeing up space and resources – he observes Marcello Pani, director of the hospital pharmacy at the Gemelli Polyclinic in Rome – The patient, self-administering the drug at home after appropriate training, will in fact leave the seats dedicated to infusions free in favor of the most suitable patients to continue the intravenous treatment. All this will lead the clinician to a series of reflections on reducing indirect costs and pressures on hospital organizations. Considering the advantages, opportunities and direct costs of the drug, the clinician will determine on which patients to use this new formulation“.
The positive opinion of Aifa – the note details – was based on the pivotal phase 3 Visible studies, born with the aim of evaluating the safety and efficacy of the subcutaneous formulation of vedolizumab as maintenance therapy in adult patients suffering from colitis moderate to severe ulcer disease or active Crohn’s disease that achieved clinical response at week 6 following two doses of vedolizumab as open label intravenous therapy at week 0 and week 24. Data from the extension study to long-term, open label, of Visible 1 and Visible 2 patients. In these studies, the subcutaneous formulation of vedolizumab was shown to be effective and well tolerated in both ulcerative colitis and Crohn’s disease patients.
“The approval of a new formulation of vedolizumab by Aifa marks a fundamental step towards a better management of IBD, disabling, chronic diseases that affect men and women of all ages – he declares Alfonso Gentile, Medical and Regulatory Director of Takeda Italy – Takeda has been committed for years to providing more options for patients with ulcerative colitis and Crohn’s disease that fit their different preferences. The availability of the pre-dosed pen and syringe represents an additional treatment option to better manage these diseases, with a significant improvement in the patient’s quality of life. Vedolizumab – he points out – thus becomes the only originator drug approved in Italy as a maintenance therapy, available both in intravenous and subcutaneous solutions: a record we are proud of “.