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news.The US Food and Drug Administration (FDA) has informed Allergy Therapeutics that the clinical hold on the investigational new drug applications (INDs) for the three MATA-MPL products will be lifted once the protocols have been agreed.
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The FDA has asked the company to submit its study protocols to the INDs for further discussions in order to provide review and feedback on the proposed studies.
Allergy Therapeutics CEO Manuel Llobet said they are encouraged that the clinical hold on all three INDs will be lifted, allowing the development programmes for these important products for treatment of allergic rhinoconjunctivitis due to grass, trees and ragweed pollen to restart.
Allergy Therapeutics Grass MATAMPL Phase III study principal investigator Lawrence DuBuske said the lifting of the clinical hold on all three INDs will allow specific injectable short course immunotherapy products to be developed using modern clinical trial methodology.
"With a course of just four injections administered ahead of the peak allergy season, compared to the current practice of up to 100 injections administered over 52 to 104 weeks, this new approach promises to transform the way allergy immunotherapy is practiced in the US," DuBuske said.