News and Media

For the first time the Republic of Bulgaria, as a Member State of the EU, will be the reference country in the decentralized procedure (DCP) for Marketing Authorisation for a medicinal products with applicant Tchaikapharma High Quality Medicines Inc., Bulgaria. The concerned parties in the procedure are Austria, Greece, Portugal, Romania, Slovakia and the Czech Republic.

As a reference party to the procedure the BDA will assess the dossier for Marketing Authorisation for medicinal products (fixed combination) with active ingredients ramipril and amlodipine. A team of the BDA will prepare evaluation reports, including questions to the applicant at any stage of the procedure. The evaluation will be consistent with the requirements of current Pharmacopoeia (Ph.Eur.), the Guidelines of the International Committee on Harmonization (ICH) and European guidelines on quality, safety and efficacy of medicinal products.

Bulgarian Drug Agency issued a new Marketing Authorisation to Tchaikapharma High Quality Medicines Inc. for the medicinal product for treatment of diabetes mellitus Aroba 100 mg tablets.

Aroba contains the active substance acarbose, and belongs to the group of medicines called alpha-glucosidase inhibitors. It is used as supplement treatment concomitantly with diet in patients with diabetes and for the prevention of type 2 diabetes in patients with demonstrated impaired glucose tolerance. The dosage should be individualized for each patient by the doctor as the efficacy and tolerability vary from individual to individual.

ATC code: A10BF 01

More information about Aroba can be found here.

The Guardian wrote that the Scientists had found that two licensed drugs stopped the degeneration of the brain in mice. The discovery gives hope of success in the search for drugs for the therapy of Alzheimer’s disease.
The results, presented at the annual conference of scientists researching Alzheimer’s disease, were defined as “promising” because the drugs used were already proven safe and well accepted by the human body. This can save years in the process of development and approval of new drugs.
Giovanna Maluchi of Cambridge University said: “This is really exciting. Medicines are licensed. This means that we go directly to the underlying clinical tests on a small group of patients, since no new ingredients, these are known drugs.” The scientists have decided not to disclose the names of the two drugs that are not currently used for the treatment of dementia in order not to cause testing from patients before the clinical trials prove their effectiveness.
The discovery is based on key study conducted two years ago, which proves that the death of brain cells can be stopped in mice by switching off the wrong signal in the brain, stopping the production of new proteins. However, the study had used a composition that causes serious side effects and was not suitable for humans. Both drugs had been identified after Maluchi’s team had examined hundreds of licensed drugs in search of a safe drug with the same protective effect on the brain.
The researchers point out that before the clinical trials a research would be conducted that would confirm that the same error signal, which was treated in mice, caused degeneration and memory loss in Alzheimer’s disease. Maluchi said that if the study would be conducted as soon as possible and would confirm that connection, the clinical trials could begin within a few years.

Prof. Marita Eisenmann predicted that after 10 years the fat grifting method will completely replace breast implants.

Three women after mammectomy due to breast cancer undergo reconstructive surgery today in Sofia First Gynecological Hospital “St. Sofia” by a Bulgarian team of specialists, led by the world-renowned plastic surgeon Prof. Marita Eisenmann – Klein. This was announced at a press conference on the opening of a seminar organized by the Cluster for Medical Tourism, International Health Association of Bavaria and the International Confederation for Plastic Reconstructive and Aesthetic Surgery IPRAS. At the meeting with the media became clear that the interventions will be implemented without the placement of implants using the method of autologous fat transfer (fat grafting) and the participation of Prof. Eisenman has a training character, it became clear. The visit of the expert is entirely in good faith, free of charge and aims to help the Bulgarian medics to master this particular methodology, which enjoys more and more supporters in the professional medical community worldwide. The operation will be monitored by a large group of doctors from Sofia and Plovdiv.

The method was extremely sparing the patient, the sessions were short, a great advantage was its universal applicability, one of the indications for its implementation was radiotherapy, said Dr. Mladen Mladenov from the surgical oncology team of Obstetrics and Gynecology Hospital “St. Sofia”. The intervention went in stages between them were provided intervals of not less than 2 months, and the number of individual sessions depended on the individual characteristics of the patient, said Dr. Mladenov.

Prof. Marita Eisenmann predicted that only after 10 years the fat grafting method would be the first choice in reconstructive breast surgery and implants would remain in the past. According to her many hopes were laid on the application of the method in urinary and anal incontinence in orthopedic surgery for arthritis and osteodegenativni diseases. “My dream is to see good results in the treatment with autologous adipose tissue of chronic wounds, especially of decubitus. I am optimistic that this will happen,” added Prof. Eisenman.

At the press conference it became clear that the surgical oncology team of Obstetrics and Gynecology Hospital “St. Sofia” was ready to apply that treatment at that time and every woman who considered that there was a need for thoracic intervention not only because of malignancy might seek consultation at the hospital. For the moment, the intervention is not paid by the NHIF, the individual stages are priced at BGN 1 200.

In the autumn of this year another training workshop with demonstrations of Bulgarian medics is foreseen, it will be dedicated to the topic of the application of new methods of plastic surgery in urology with focus on urinary incontinence.

There are reported cases of serious, sometimes life-threatening cases of diabetic ketoacidosis in patients with type 2 diabetes treated with SGLT2-inhibitors. This is reported by the manufacturers after consultation with the European Medicines Agency (EMA) and the Bulgarian Drug Agency (BDA).

In a number of these reports the clinical presentation of the condition is atypical, as only moderately elevated blood glucose levels are observed. The statement says that such atypical clinical presentation of diabetic ketoacidosis in patients with diabetes could delay diagnosis and treatment.

The patients treated with inhibitors of SGLT2, with symptoms of acidosis should be tested for ketones to prevent the delay in diagnosis and treatment.

Cases of diabetic ketoacidosis have also been reported in patients with type 1 diabetes mellitus, who were given inhibitors of SGLT2. The pharmaceutical companies remind the prescribing physicians that type 1 diabetes is not permitted therapeutic indication for this class of drugs.

In Bulgaria dapagliflozin is registered from this class of inhibitors under the trade name Forxiga 100 mg x 30.