The FDA approved the use of the drug ILUMYA® (tildrakizumab-asmn) produced by Sun Pharmaceutical Industries adult patients for the treatment of moderate and severe plaque psoriasis on the basis of the program of clinical trials (CI) late-stage reSURFACE.
In two multicenter randomized double-blind placebo-controlled studies (reSURFACE reSURFACE 1 and 2) participated 926 adult patients who received ILUMYA™ (N=616) or placebo (N=310). The drug ILUMYA® selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the receptor of IL-23, which leads to inhibition of the release of anti-inflammatory cytokines and chemokines. The drug ILUMYA® is administered subcutaneously at a dose of 100 mg for 12 weeks after administration of the initial doses at 0 and 4 weeks.
The results of these studies were published in the Lancet in July 2017, and the results of the primary endpoint were presented at the XXVII Congress of the European Academy of dermatology and venereology (EADV).
“The approval of the drug ILUMYA® and our long-standing commitment to dermatology allows us to focus on how to improve the lives of people suffering from moderate to severe plaque psoriasis,” said Abhay Gandhi President and chief Executive Director of Sun Pharma in North America.
“We are determined to cooperate with all who are interested in how to make the drug ILUMYA® is available for people suffering with plaque-type psoriasis”.
The drug ILUMYA® is contraindicated in patients with a prior serious hypersensitivity reaction to childrensomaha or any of the excipients.
Drug treatment ILUMYA® should not be administered to patients with clinically significant infection in the active phase until then, until the infection is fully cured.
The appointment of a drug ILUMYA® to evaluate patient for the presence of tuberculosis infection. The treatment of latent tuberculosis infection prior to prescribing ILUMYA®.
The appointment of a drug ILUMYA®, you must decide on the withdrawal of all age-appropriate immunizations in accordance with the applicable rules of immunization. Avoid use of live vaccines in patients receiving the drug ILUMYA®.
Among the most common (≥1%) adverse reactions associated with the drug ILUMYA®, marked infection of the upper respiratory tract, reactions at the injection site and diarrhea. Adverse reactions, frequency of which was less than 1% but more than 0.1% in the group ILUMYA®, and which occurred more frequently than in the placebo group included dizziness and pain in the limbs.
Psoriasis is a chronic immune skin disease. It is not contagious violation, which accelerated the growth cycle of skin cells and appears thick scaly layer on the skin. The most common form of this disease, which occurs in 80– 90 percent of people with psoriasis is plaque psoriasis. It manifests itself in the form of red, exposed areas of the skin covered with white scales that can cause itching and soreness, cracking and bleeding. Many people with plaque psoriasis suffer constantly from an enduring, permanent nature of this chronic disease.
Source: Sun Pharmaceutical Industries