Lack Of Ragwitek Efficacy Data In Older Patients No Hurdle To Panel Nod
FDA advisory committee endorses the sublingual ragweed pollen allergy immunotherapy for patients ages 18-65 years even though Merck’s efficacy studies only went up to age 50. The sponsor conducted safety studies in older patients and presented other data to support an inference of efficacy in the over-50 population.
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Experience and data from the study, which will use the same vector platform to deliver different transgenes for different diseases, could feed into the US FDA’s efforts to establish a public-private partnership to enable manufacturing of gene therapies for ultra-rare diseases.
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.
Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.