Four medicines have taken a giant leap closer to approval having won the backing of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Janssen’s Erleada (apalutamide) received a positive opinion for the treatment of non-metastatic castration resistant prostate cancer.
The drug, a selective androgen receptor inhibitor that binds directly to the ligand binding domain of the androgen receptor, has been shown to delay metastatic disease in trials. The most common side effects are fatigue, skin rash, weight decrease, arthralgia and falls.
The CHMP also backed a marketing authorisation for Aeterna Zentaris’ Macimorelin Aeterna Zentaris (macimorelin) for the diagnosis of growth hormone deficiency in adults.
Macimorelin stimulates growth hormone release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.
According to the Committee, the benefit with Macimorelin Aeterna Zentaris is its ability to confirm diagnosis of growth hormone deficiency with high sensitivity and specificity in adult patients. The most common side effects are dysgeusia, dizziness, headache, fatigue, feeling hot, nausea and diarrhoea.
Recordati’s generic Silodosin Recordati (silodosin) was endorsed to treat the signs and symptoms of benign prostatic hyperplasia, by decreasing the bladder outlet resistance and improving storage (irritative) and voiding (obstructive) lower urinary tract symptoms.
The product is a generic of Urorec, which has been authorised in the EU since 29 January 2010. The CHMP said studies have shown the satisfactory quality of Silodosin Recordati.
The CHMP also adopted a positive opinion for use of Sanofi’s Fexinidazole Winthrop (fexinidazole), the first oral-only medicine for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense.
This marks the tenth medicine recommended by the EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on medicines for use outside the European Union.
As an exclusively oral treatment regimen for the disease, Fexinidazole Winthrop could potentially allow quicker and wider access to treatment because distribution and administration of tablets is easier, the Committee noted.
The drug was developed by Sanofi in partnership with the Drugs for Neglected Diseases initiative, a non-profit drug research and development organisation based in Switzerland.