The European Medicines Agency (EMA) said on September 2nd that it was evaluating Taw Pharma's steroid drug Dexamethasone Taw as a potential treatment for adult patients with COVID-19.
EMA Human Drug Board (CHMP) has been reviewing Taw Pharma's listing application since August 31.
application for the drug was submitted by Taw Pharma, a British consultancy, on behalf of an undecloded pharmaceutical company and is under review under the EMA Accelerated Review Path.
Taw Pharma said it could not disclose the customer's name because of a nondisclosure agreement for the company that is developing Semisson Taw.
this is the second drug reviewed by the EMA for COVID-19 patients, after the EMA conditionly approved Gilead's antiviral drug Veklury in July for adult and adolescent COVID-19 patients who needed oxygen supplementation (i.e., severe illness).
is an ancient and widely used corticosteroid that has become one of the most promising treatments for COVID-19.
a large randomized controlled trial of multiple COVID-19 therapies in the United Kingdom, recovery results showed that the number of deaths in the dexemisson treatment group was lower among patients admitted to hospital for severe respiratory complications of COVID-19.
EMA noted that prior to receipt of Taw Pharma's application, a review of the results of the RECOVERY trial had been begun to make recommendations on the use of local symethon drugs for COVID-19.
EMA indicated that the results of the review would be taken into account in the review of Taw.
said it was "reviewing the listing permit application in the shortest necessary time necessary to conduct a comprehensive assessment of the benefits and risks of the drug."
" regarding the latest results of the RECOVERY trial, the EMA explains that 29 percent of patients treated with dexamisund died within 28 days of starting use, compared with 41 percent of patients receiving routine care, a relative decrease of about 35 percent.
patients who took oxygen without mechanical aeration, the mortality rate in the dexamisong group was 23% over 28 days, compared with 26% in the conventional care group.
patients who did not receive oxygen therapy or mechanical aeration, there was no reduction in mortality.
Taw is being developed as a hybrid medicine.
mix" means a 'reference drug' similar to the one containing the same active ingredient (in this case, Fortecortin Inject), but in some respects it varies, such as specifications, uses, or dosage forms.
like Fortecortin Inject, dexamison Taw will be used as an injection and, if approved, for the treatment of the same condition as Fortecortin Inject plus COVID-19.
" dexamisson has been licensed for decades to treat a variety of diseases, including rheumatism, skin disease, severe allergies, asthma and chronic obstructive pulmonary disease, due to its anti-inflammatory properties.
EMA said the review of the Taw application would not "have an impact on the use of other dexamisong drugs."