2019, a new year of “progress” and “remarkable progress” for pharmaceutical innovation
The European agency EMA gives green light to 30 new drugs and the US FDA, to 48
Hematology and oncology account for more than a third of the new approvals, and almost one in four are therapies for rare diseases
Source: www. farmaindustria.es
The European Medicines Agency (EMA) has released on Thursday its annual report on the main developments in the field of drug approval, in which it recalls that “advances in drug authorizations are essential for the progress of public health, since they provide new opportunities to treat certain diseases ”, and that reveals that in 2019 it gave the green light to 30 completely new drugs and issued a total of 66 positive opinions. With this data, Europe has approved 173 new medicines in the last 5 years, reflecting the research effort of the pharmaceutical industry to respond to millions of patients.
In 2019, the area that has most monopolized has been hematology, followed by cancer, infectious and endocrinology, although European specialists in neurology, ophthalmology, cardiovascular, metabolism, rheumatology, psychiatry and dermatology have also increased their therapeutic arsenal.
In addition, the regulatory authority has approved a new vaccine in the exercise that has just ended. This is the first immunization against Ebola, a serious disease that can reach mortality rates of 90%. Precisely this vaccine is one of the 8 new products that the EMA highlights in its report for having supposed “significant progress in its therapeutic areas”. In this selection there are also two drugs for diabetes.
Protagonism of orphan drugs
Of the 30 developments it is important to underline that seven (almost one in four) are therapies considered orphaned, which once again highlights the commitment of the innovative pharmaceutical industry to the area of ??rare or rare diseases, a constant demand among Patient associations Also, among this thirty new substances highlights a new therapy considered “advanced”, this time to treat patients with beta thalassemia.
With regard to the type of authorization procedure, it should be stressed that a third of the new medicines have been approved by special evaluation schemes: expedited, conditional processing or under exceptional circumstances in response to unmet medical needs.
FDA activity
In the same positive sense, the US regulatory agency, FDA, whose Drug Evaluation and Research Center (CDER) considers the 48 new drugs approved in 2019 to be a remarkable advance this week.
And the FDA has also made public this week its approval data, somewhat above the European figures, but also the area of ??hematology and oncology and the innovative response in rare diseases.
“More important than the amount of new therapies is their medical value and the new roles that these medications are fulfilling to advance patient care,” values ??the New Drug Therapy Approvals 2019 report. Advancing Health Through Innovation.
In Distefar we support this type of actions. The pharmaceutical industries are essential in terms of research and advances to treat certain diseases.
