Pharming Group N.V. announces that a positive decision has been made by the European Medicines Agency (EMA) on the Paediatric Investigation Plan (PIP) for leniolisib, a phosphoinositide 3-kinase (PI3K) inhibitor, currently in development for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS).
Source:- Pharming Group N.V.
According to a literature survey, in the United States, 1.75 to 2.3 patients are being diagnosed per million populations. Patients with APDS had a high incidence and wide range of inflammatory/autoimmune manifestations. Enhanced PI3Kd activity has been reported in patients with autoimmune diseases, such as systemic lupus erythematosus and PI3Kd modulates the regulatory T-cell function
Comprehensive insight on patient segmentation based on age, sex, Types (APDS-1 & APDS-2), Signs & Symptoms, Clinical Manifestations (Recurrent-RTI, Pneumonia, Bronchiectasis, Herpesvirus infections, Lymphadenopathy, Splenomegaly, Autoinflammatory disease, Neurodevelopmental delay, and Lymphoma) has been provided into the epidemiology section of the APDS and its treatment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China
In terms of pharmacologic therapies, there are few drug candidates are in different Phase (Phase I, II & III) stages of development. Key companies are, Pharming Group N.V./ Novartis; leniolisib (CDZ173), GSK uses an inhaled PI3K? inhibitor nemiralisib (GSK2269557) that had been originally developed for the treatment of COPD, TG Therapeutics, Inc.; TGR-1202 and Rhizen Pharmaceuticals SA; Tenalisib is aggressively working around building the portfolio. From the study, NCT02435173 has been found well-tolerated and normalization of circulating transitional and naïve B cells, reduction in senescent T cells, decrease in the elevated serum IgM levels, and inflammatory markers.
Thelansis is specialized in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area which includes both rare / ultra-rare and mainstream indication. Over the period of time, we have built a strong repository of 6,000+ Bio-pharma reports which essentially covers Epidemiology study and Market forecasting based on the KOL opinions. Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the major focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.
Gurugram- Onework Gold Souk mall, Phase I, Sector 43, Haryana-122002, India
Contact no.: +91(124) 404-1731
183-Asylum Street Hartford, CT-06103, USA
USA +1 (267) 244-6955,