Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2025

The committee beneficial to increase the use of authentic Spikevax vaccine and Spikevax bivalent Original/Omicron BA.1 as a booster dose in children aged 6 to 11 years. The committee really helpful changing the conditional advertising authorisation of the COVID-19 vaccine Jcovden to a standard advertising authorisation. An overview of all the COVID-19 vaccines authorised within the EU is obtainable on EMA’s webpage. The agenda of the December 2022 CHMP meeting is printed on EMA's web site. Minutes of the November 2022 CHMP assembly will probably be published in the coming weeks. Key figures from the December 2022 CHMP meeting are represented within the graphic below. This product was designated as an orphan drugs during its improvement. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to find out whether the data available so far allows maintaining the medicine’s orphan standing and granting the medicine ten years of market exclusivity.Classic infantile-onset Pompe disease sometimes begins with enzyme replacement therapy (ERT) as soon as a prognosis is made. In ERT, CircuPulse the infant is repeatedly treated with an artificial copy of the acid alpha-glucosidase enzyme. One research showed that babies treated with ERT earlier than 6 months had increased survival charges in addition to the ability to breathe and not using a ventilator. The 2017 study additionally discovered that ERT treatment led to better coronary heart health and improved studying of motor abilities. While ERT isn’t a cure for Pompe illness - no cure at present exists - it may possibly improve high quality of life and CircuPulse improve life expectancy. In addition to ERT therapy, remedies that tackle breathing difficulties, bother swallowing, CircuPulse and bodily points are usually also mandatory. Sometimes a feeding tube is part of treating infantile Pompe disease, an effort to make sure correct nutrition. Sometimes, smooth or pureed foods are introduced before resorting to a feeding tube.There is evidence that decreased glycogen levels in the mind could cause neurological disruption. The presence of glycogen within the brain has been acknowledged for many years, but it is just just lately that it has been assigned practical roles. It occurs at too low a concentration to be thought of a conventional power reserve, and must be thought-about as a buffer to provide energy substrate within the form of glycogen derived lactate, which is transported intercellularly to gasoline neurones throughout periods of elevated vitality demand, equivalent to occurs during the means of studying and reminiscence. AB was responsible for the conception of the evaluation. WH and LR contributed to the assessment and accepted the ultimate version of the manuscript. This work was supported by the Biotechnology and Biological Sciences Research Council (Grant Number BB/M008770/1) through a BBSRC DTP. The authors declare that the analysis was carried out within the absence of any industrial or monetary relationships that may very well be construed as a possible battle of curiosity.