![\"EMA](\"https:\/\/mikrobiomik.net\/wp-content\/uploads\/plan-de-investigacion-pediatrica-para-mbk-01.jpg\")
<\/h2>\nMikrobiomik has reached a new milestone upon receiving the approval of the Paediatric Investigation Plan (PIP) from the European Medicines Agency (EMA) for the treatment of Clostridioides difficile<\/em> infection (CDI) in paediatric patients.<\/h2>\n <\/p>\n
This approval represents a fundamental step in the regulatory process that we have initiated with the aim of bringing our investigational medicine MBK-01 to market.<\/p>\n
The PIP is a regulatory requirement in the European Union designed to ensure that medicines under development are evaluated in the paediatric population, as long as it is scientifically viable and clinically relevant.<\/p>\n
Following evaluation by the EMA Paediatric Committee, a PIP for the treatment of primary refractory and recurrent Clostridioides difficile<\/em> infection in a group of patients aged between one and 18 years has been approved. The plan establishes the supply of MBK-01 in a gastro-resistant capsule pharmaceutical form suitable for administration to this population.<\/p>\nAs part of the official statement, a postponement has been granted in the execution of the PIP, allowing the paediatric trial to be carried out at an appropriate time within the drug development process. Likewise, a waiver has been granted for the subgroup of paediatric patients under one year of age, for whom the drug does not provide a significant therapeutic benefit over existing treatments.<\/p>\n
The EMA’s validation of the PIP supports the scientific robustness of the development of MBK-01 and allows progress in its regulatory process, paving the way for its future approval and market access.<\/p>\n
The approval of this plan represents a milestone on the road to the availability of innovative treatments, and Mikrobiomik continues to consolidate its leadership in the field of gut microbiota-based drugs.[\/vc_column_text][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"
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EMA approves the Pediatric Investigation Plan for MBK-<\/title>\n<meta name=\"description\" content=\"Good news: EMA approves the Paediatric Investigation Plan (PIP) for the treatment of Clostridioides difficile infection,\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mikrobiomik.net\/en\/good-news-ema-approves-paediatric-investigation-plan-pip-for-mbk-01\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EMA approves the Pediatric Investigation Plan for MBK-\" \/>\n<meta property=\"og:description\" content=\"Good news: EMA approves the Paediatric Investigation Plan (PIP) for the treatment of Clostridioides difficile infection,\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mikrobiomik.net\/en\/good-news-ema-approves-paediatric-investigation-plan-pip-for-mbk-01\/\" 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As part of the official statement, a postponement has been granted in the execution of the PIP, allowing the paediatric trial to be carried out at an appropriate time within the drug development process. Likewise, a waiver has been granted for the subgroup of paediatric patients under one year of age, for whom the drug does not provide a significant therapeutic benefit over existing treatments.<\/p>\n
The EMA’s validation of the PIP supports the scientific robustness of the development of MBK-01 and allows progress in its regulatory process, paving the way for its future approval and market access.<\/p>\n
The approval of this plan represents a milestone on the road to the availability of innovative treatments, and Mikrobiomik continues to consolidate its leadership in the field of gut microbiota-based drugs.[\/vc_column_text][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"
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