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.
Activated PI3Kdelta Syndrome (APDS) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2020 To 2030
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.
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