Soligenix (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has been granted a Pediatric Investigation Plan (PIP) product-specific waiver from the Medicines and Healthcare products Regulatory Agency (MHRA) for HyBryte™ (SGX301 or synthetic hypericin), which has successfully concluded a Phase 3 pivotal clinical study for the treatment of early stage cutaneous T-cell lymphoma (CTCL).
The waiver was provided for all subsets of the pediatric population from birth to less than 18 years of age on the grounds that clinical studies in this rare population are not feasible. Earlier this year the European Medicines Agency (EMA) also granted a waiver to the Pediatric Investigational Plan requirements for the European Union (EU). With the withdrawal of the United Kingdom (UK) from the EU effective January 1, 2021, the MHRA became the UK’s standalone medicines and medical devices regulator.
“This achievement is an important regulatory milestone as we move forward with marketing applications worldwide,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “The PIP waiver allows us to work towards advancing a marketing authorization application (MAA) in the UK in a more cost-effective manner since we will not need to expend resources to conduct a pediatric clinical study.”
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