Nuclear emergencies, approved an exceptional drug also in Europe. That’s what it is used for

In the way completely exceptional, the Committee for medicines for human use (CHMP) ofEuropean Agency for Medicines (Ema) authorized the entry of a drug on the market, which has SargramosTim as its active ingredient. As reported by the Medscape platformit is a product intended for the treatment of people affected by acute radiation hematopoietic syndrome (H-Ars) following an acute exposure with myelosoppressive doses of radiation.

Acute radiation hematopoietic syndrome, what it is

The H-Ars occurs when radiation they suppress the hematopoiesis of the bone marrow (i.e. the formation of blood cells, such as red blood cells, white blood cells and platelets), with consequent increase in the risk of infections and bleeding. It occurs after doses of radiation to the whole body of about 1-6 GY, most of the time associated with acute exhibitions following radiological or nuclear emergencies.
In addition to the risk of infection, the symptoms of acute radiation hematopoietic syndrome may include anemia, petecchie and prolonged hemorrhages, which start 1-6 hours after exposure and last up to 48 hours.

SargramosTim, as the new drug acts

SargramosTim stimulates the colonies of granulocyte-macrophagus. In other words, it contrasts the H-Ars by inducing the bone marrow to produce immunoprotective leukocytes, including grains, macrophages and monocytes, as well as red blood cells and platelets.

The positive opinion on the placement on the market received by the EMA is to mean that the treatment is now indicated for patients of all ages affected by H-Ars following acute exposure to myelosoppressive doses of radiation.
In the United States it has already been used also for the treatment of patients from 2 years forward to prevent serious infections in conditions such as the leukemiaThe bone marrow transplantation and the Collection of blood cells before chemotherapy.

In which cases a “exceptional” drug is authorized

The drugs can be authorized in exceptional circumstances, subject to some specific obligations, when the applicant has not been able to provide complete data on the effectiveness and security of the drug in normal conditions of use. This may be due to the fact that the condition for which the drug must be used is too rare for an in -depth collection of data; due to the limited scientific knowledge in the area concerned; or because the collection of complete information is not possible or is not ethics. The authorization in exceptional circumstances must be reviewed annually.

The Committee for medicines for human use He said that three randomized studies, blind, controlled with placebo, conducted on rhesus monkeys subjected to total body irradiation with induction of H-Ars, have shown that the drug has increased survival rates at 60 days compared to placebo. Studies have also demonstrated a faster recovery of neutrophils and platelets, a reduction in infection rates and fewer sepsis signs.