Lofarma leads the process: fullfillment of Therapeutic Allergen Directive in Germany
Since more than 5 years now Lofarma Deutschland GmbH is representing the German subsidiary of Lofarma SpA, one of the leaders in allergy immunotherapy in Italy.
Although Lofarma has deeply validated its only sublingual monomeric allergoid in tablet for allergy immunotherapy with more than 40 scientific publications in renown journals such as Lancet, Allergy, JACI etc., due to specific German regulatory issues, the clinical validation has to be reinforced with new trials in order to achieve a registration for the German market.
Therefore, Lofarma has set up a large clinical trial programme called SMART (Sublingual Monomeric Allergoid Registration Trials) in oder to fullfill the demands of the 2008 implemented Therapeutic allergen directive issued by Paul-Ehrlich-Institute in Germany.
The SMART clinical trials programme contains a clinical validation coming from dose finding trials, phase III trials in adults on efficacy and safety as well as children phase III trials on efficacy and safety. The aim is to register 7 major important products available as monomeric allergoids for sublingual tablets, drops and for subcutaneous immunotherapy given the latest standards in state-of-the-art regulatory trials.
The programme already started in 2012 and has been performed with 5 clinical trials in allergens such as Mites, Grass and Trees officially approved by Paul-Ehrlich-Institute.
From these trials, the first dose finding trials have been successfully finished in more than 300 patients and more than 400 patients are currently included in the remaining double-blind, placebo controlled clinical trials.
Thus, Lofarma is strongly enforcing its clinical validation and is ahead in terms of approved clinical Therapeutic allergen directive trials compared to its competitors in Germany. The first registrations are to be expected for early 2015 in Germany (firstname.lastname@example.org).