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Round-up
FDA approves measles vaccine
The FDA has approved Priorix for active immunisation for the prevention of measles, mumps, and rubella (MMR) in individuals 12 months of age and older.
Priorix is currently licenced in more than 100 countries worldwide, including all European countries, Canada, Australia, and New Zealand.
“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunisation. Missed vaccinations during the COVID-19 pandemic makes children even more vulnerable to vaccine-preventable diseases like measles,” said Temi Folaranmi, MD, Vice President and Vaccines Therapeutic Area Head, US Medical Affairs, GSK. “Making Priorix available to patients in the US will ensure healthcare professionals have more than one option for this critical vaccine as they work to catch their patients up on recommended vaccinations.”
MMR are acute and highly contagious viral diseases, responsible for considerable global morbidity and mortality. In recent years, measles outbreaks have occurred in the US and globally, with more than 400,000 cases confirmed in 2019.
FDA refuses to fully review Aeglea’s rare disease drug application
FDA administrators issued a refusal to file for the Aeglea BioTherapeutic’s biologic, pegzilarginase, sharing the agency will not decide until the company turns over clinical data that demonstrate a treatment effect.
The therapy is for patients with arginase-1 deficiency (ARG1-D), a rare genetic disorder that can cause seizures, spasticity, and intellectual disability in untreated children.
ARG1-D is a rare recessive genetic disease that affects children, and is passed through hereditary genetics. It can lead to severe disorders if left untreated, and affects anywhere from 1 in 300,000 and 1 in 1,000,000 births.
“We intend to work collaboratively with the FDA to identify a viable path forward to demonstrate that lowering plasma arginine confers clinical benefit,” said Anthony Quinn, PhD, president and CEO of Aeglea.
The therapy is for patients with arginase-1 deficiency (ARG1-D), a rare genetic disorder that can cause seizures, spasticity, and intellectual disability in untreated children.
ARG1-D is a rare recessive genetic disease that affects children, and is passed through hereditary genetics. It can lead to severe disorders if left untreated, and affects anywhere from 1 in 300,000 and 1 in 1,000,000 births.
“We intend to work collaboratively with the FDA to identify a viable path forward to demonstrate that lowering plasma arginine confers clinical benefit,” said Anthony Quinn, PhD, president and CEO of Aeglea.