News 15.08.19

The Mirpharm company starts the production of the drug product unique to the Russian market for the treatment of food allergy

The Mirpharm company announces the registration and availability for the acquisition of a new oral drug product Cromoglycic acid for the treatment of food allergy as a monotherapy or in combination with a diet. This drug product has no analogues in Russia

With food allergy, any substance, most often of a protein nature, can stimulate the production of IgE or a cell-mediated immune response. In this case, patients can experience various clinical manifestations from mild to severe degree, as well as life-threatening: urticaria/angioedema, nausea, vomiting, abdominal pain and diarrhea, anaphylaxis and others. One of the key elements in the development of an allergic reaction at food allergy is mast cell degranulation.


Cromoglycic acid has a stabilizing effect on mast cell membranes, thereby preventing the release of histamine, bradykinin, leukotrienes and other inflammatory mediators from them. The drug product has a good tolerance profile. It is minimally absorbed from the gastrointestinal tract (<1%) and excreted in the unchanged form. This drug product is well suited for long-term use. Cromoglycic acid is well known to Russian doctors and is widely used in the treatment of various allergic diseases (bronchial asthma, allergic conjunctivitis, etc.). However, its oral form was not available in our country until recent times.


The Ministry of Health of the Russian Federation decided to register the drug product in accordance with the considered registration dossier. Currently, the drug product is already available for purchase in the retail network.


On the part of the medical community, the chief non-staff children's allergologist-immunologist specialist of the Ministry of Health of the Moscow Region, the chief specialist in pediatrics of the State Budgetary Healthcare Institution Children's Municipal Clinical Hospital No. 9 named after G.N. Speransky, the head of the Department of Immunology, Allergology and Immunotherapy of the Non-state Educational Private Institution of the Further Vocational Education Higher Medical School, M.D., professor Prodeus Andrew Petrovich shared his opinion: “The oral form of cromoglicic acid is an important element in the treatment of food allergy and other atopic conditions, especially given their high prevalence in children and an extremely limited number of pharmacological agents in the doctor’s inventory. We are confident that this drug product will benefit to (the) patients and will be in demand by the medical community”.


About food allergy

The prevalence of proven food allergy among young children in developed countries is 6–8%, in adolescents and adults it is 2–4%. At the same time, a history of food allergy symptoms are (is) noted in 17.3% of children. Among children suffering from atopic dermatitis, the frequency of food allergy exceeds 30%. The so-called "Big Eight" of the products that most often cause allergic reactions include the following: cow's milk, hen's egg, peanuts, nuts, fish, seafood, wheat and soy [1-4]. Cross-allergic reactions to various food products, as well as other allergens (mainly pollen and epidermal), which are caused by the presence of proteins similar in structure in their composition, are of great practical importance.

Sources:

  1. Instruction on medical use of the drug product Cromoglycic acid
  2. Food allergy, clinical guidelines of the Union of Pediatricians of Russia, 2016
  3. Food Allergy and Anaphylaxis Guidelines, European Academy of Allergy and Clinical Immunology, 2014


Note:

The press release contains information about prescribed drug products. The use of this information for the preparation of publications should be made in accordance with the legislation of the Russian Federation on advertising (including, but not limited to article 24 of the Federal Law dated 13.03.2006 No.38-ФЗ On Advertising). According to the legislation, in particular, advertising of prescribed drug products is permitted only at medical or pharmaceutical exhibitions, seminars, conferences and other similar events, as well as in specialized print media for medical and pharmaceutical specialists. Failure to comply with these requirements (namely, mentioning the name of the drug product, placing the image of the package or its elements in the media not related to specialized print media intended for medical and pharmaceutical specialists) results in administrative liability.

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