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Long-lasting buprenorphine implant recommended by EMA committee

As well as bupronorphine implant Sixmo as a substitute treatment for opioid dependence, the European Medicines Agency agreed positive opinions for turoctocog alfa pegol (Esperoct); ravulizumab (Ultomiris); HIV treatment dolutegravir/lamivudine (Dovato); and botulinum toxin type A (Nuceiva).

A long-lasting implant has been recommended for marketing authorisation as a substitution treatment for opioid dependence by the European Medicines Agency’s (EMA) human medicines committee (CHMP).

Sixmo (Molteni Farmaceutici) releases low levels of buprenorphine, an opioid partial agonist/antagonist, into the patient’s body for six months.

According to the CHMP’s summary of opinion, the benefit with Sixmo is its ability to substitute for opioids during addiction treatment. It is indicated for “clinically stable adult patients who require no more than 8mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment”.

It is proposed that the implant be prescribed by physicians experienced in the treatment of opioid dependence.

The most common side effects experienced with use of Sixmo are implant-related adverse events, headache, constipation and insomnia.

During its April 2019 meeting, the CHMP also agreed a positive opinion for two orphan medicines: turoctocog alfa pegol (Esperoct; Novo Nordisk A/S) for the treatment and prophylaxis of bleeding in patients aged 12 years and above with haemophilia A; and ravulizumab (Ultomiris; Alexion Europe SAS) for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

A positive opinion was also adopted for HIV treatment dolutegravir/lamivudine (Dovato; ViiV Healthcare B.V.) and botulinum toxin type A (Nuceiva; Evolus Pharma Ltd) for the temporary improvement of vertical lines between the eyebrows, when the severity of the facial lines has a psychological impact in adults aged under 65 years.

The CHMP adopted a negative opinion refusing a marketing authorisation for a drug intended to treat prostate cancer, cabazitaxel (Cabazitaxel Teva; Teva B.V.). Cabazitaxel was developed as a hybrid medicine, meaning it was intended to be similar to the reference medicine, Jevtana, containing the same active substance and already authorised in the EU.

However, the CHMP said that it did not agree that the data presented by the pharmaceutical company were sufficient to support the claim that cabazitaxel and docetaxel should be considered the same active substance.

The agenda and minutes for the CHMP’s meetings are available to view on the EMA website.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206484

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