Dexxience

Refused

This medicine has been refused authorisation

betrixaban

Overview

On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dexxience, intended for the prevention of venous thromboembolism. The company that applied for authorisation is Portola Pharma UK Limited.

The company requested a re-examination of the initial opinion. After considering the grounds for this request, the CHMP re-examined the opinion and confirmed the refusal of the marketing authorisation on 26 July 2018.

What did the company present to support its application of Dexxience?

The company presented the results of one main study involving over 7,500 adults who had been admitted to hospital for a recent medical illness. The patients were at high risk of venous thromboembolism because of their age, presence of a protein indicating a blood clot, previous blood clots, cancer and lack of mobility during hospital treatment. Treatment with Dexxience was compared with enoxaparin, another medicine for preventing blood clots. The main measure of effectiveness was the occurrence of deep vein thrombosis (blood clot in a deep vein, usually in the leg), or of pulmonary embolism (blood clot in the lung), or death from a blood clot.

What were the CHMP’s main concerns that led to the refusal of Dexxience?

The CHMP considered that the main study did not satisfactorily show Dexxience’s effectiveness when used for preventing blood clots in patients admitted to hospital for recent medical illness. Also, patients treated with Dexxience had more episodes of bleeding than those treated with the comparator medicine. This was considered an important concern given that the medicine was expected to be used in patients with serious underlying conditions for whom any episode of bleeding could have serious consequences, and Dexxience’s long persistence in the body could complicate management of bleeding.

Therefore, at that point in time, the CHMP was of the opinion that the benefits of Dexxience did not outweigh its risks and recommended that it be refused marketing authorisation. The CHMP refusal was confirmed after re-examination.

What consequences does this refusal of Dexxience have for patients in clinical trials?

The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Dexxience.

If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the clinical trial.

Questions and answers on refusal of the marketing authorisation for Dexxience (betrixaban) - Outcome of re-examination

Reference Number: EMA/501901/2018

Product details

• Name of medicine:
  Dexxience
• Active substance:
  betrixaban maleate
• International non-proprietary name (INN) or common name:
  betrixaban
• Therapeutic area (MeSH):
  Venous Thromboembolism
• Anatomical therapeutic chemical (ATC) code:
  B01AF

Pharmacotherapeutic group

Antithrombotic agents

Application details

• EMA product number:
  EMEA/H/C/004309
• Marketing authorisation applicant:
  Portola Pharma UK Limited
• Opinion adopted:
  26/07/2018
• Refusal of marketing authorisation:
  20/09/2018