At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
In its latest meeting, the CHMP recommended granting a marketing authorisation for Awiqli (insulin icodec) for diabetes mellitus in adults, and Lytenava (bevacizumab) as a treatment for neovascular age-related macular degeneration.
Following accelerated assessment by the EMA, its human medicines committee also adopted a positive opinion for Emblaveo (aztreonam-avibactam) as a new antibiotic against Gram-negative bacteria resistant to available antibiotics.
Fabhalta* (iptacopan) was given a positive opinion from the CHMP as the first oral monotherapy for the rare blood disorder paroxysmal nocturnal haemoglobinuria (PNH). The decision was based on two Phase III trials. According to EMA, Fabhalta enabled 51 of 60 evaluable patients to attain haemoglobin improvement (≥2 g/dl). There were 42 of these individuals who achieved sustained haemoglobin levels (≥12 g/dl) in the absence of transfusion. This was compared to zero patients who were treated with the anti-C5 regimen.
Biosimilars recommendations by the CHMP
The committee adopted positive opinions for three biosimilars:
- Jubbonti (denosumab), for the treatment of osteoporosis and bone loss.
- Omlyclo (omalizumab), for the treatment of asthma, severe chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria.
- Wyost (denosumab), for the prevention of skeletal related events with advanced malignancies.
The CHMP recommended Agilus* (dantrolene sodium, hemiheptahydrate) for the bone condition malignant hyperthermia.
A marketing authorisation (PUMA) was recommended for Neoatricon (dopamine hydrochloride), for treating hypotension in paediatric patients.
The committee also gave positive opinions to three generic medicines for treating patients aged 13 years and over with relapsing remitting multiple sclerosis (MS):
- Dimethyl fumarate Accord (dimethyl fumarate)
- Dimethyl fumarate Mylan (dimethyl fumarate)
- Dimethyl fumarate Neuraxpharm (dimethyl fumarate).
Treatment indication extensions
Indication extensions for six medicines already authorised in the EU were were recommended by the CHMP: Bimzelx, Nilemdo, Nustendi, Onivyde pegylated liposomal*, Retsevmo and Xtandi.
Separately, further to a review by the CHMP, the pancreatic enzyme replacement therapy Micrazym, a marketing authorisation was recommended in the Netherlands and in EU Member States where the company has applied for a marketing authorisation. According to the EMA, the decision follows a disagreement among Member States on the authorisation of the treatment via national procedures.
*This product was designated as an orphan medicine during its development.
Related drugs
Agilus, Antibiotics, Awiqli, Bimzelx, Biosimilars, Dimethyl fumarate Accord, Dimethyl fumarate Mylan, Dimethyl fumarate Neuraxpharm, Emblaveo, Fabhalta, Jubbonti® (denosumab-bddz), Lytenava, Micrazym, Neoatricon, Nilemdo, Nustendi, Omlyclo (omalizumab), Onivyde pegylated liposomal, Retsevmo, Wyost® (denosumab-bddz), Xtandi (enzalutamide)
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