Six new medicines, including a new antibacterial and therapies for multiple sclerosis and Parkinson’s disease, have jumped closer to European approval, after winning backing from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
AstraZeneca’s Zavicefta (ceftazidime/avibactam) was recommended as a new treatment option for multi-drug resistant bacteria in adults with intra-abdominal infection, urinary tract infection, and hospital-acquired pneumonia. It is also indicated for the treatment of adults with infections caused by certain Gram-negative bacteria, for which there are only limited treatment options.
Zavicefta is a fixed combination of avibactam, a new beta-lactamase inhibitor, and ceftazidime, an antibiotic belonging to the class of third generation cephalosporins already approved for use in the EU. Resistance to cephalosporins and other antibiotics is on the rise, in particular in Gram-negative bacteria; by inhibiting the action of beta-lactamases, which play a key role in the development of bacterial resistance to such antibiotics, avibactam restores the activity of ceftazidime.
Bial’s Ongentys (opicapone) received a positive opinion from the Committee for the treatment of Parkinson’s disease and motor fluctuations.
Ongentys is indicated as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with the disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
According to the Agency, the benefits of the drug are its ability to decrease off-time (time when patients are severely restricted by their symptoms) and increase on-time without troublesome dyskinesia. The most common side effects are dyskinesia, constipation, insomnia, dry mouth and dizziness.
Gilead’s single-pill therapy Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) has won backing for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 and older.
Specifically, the treatment is intended for HIV patients without known mutations associated with resistance to the NNRTI class, tenofovir or emtricitabine and with a viral load less than 100,000 copies/ml.
Odefsey is Gilead’s their TAF-based regimen to win CHMP favour. TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate; TDF), as well as improvement in surrogate laboratory markers of renal and bone safety.
The Committee also recommended granting a marketing authorisation for Biogen Idec’s Zinbryta (daclizumab) for the treatment of relapsing forms of multiple sclerosis.
The drug is a new form of a humanised monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) expressed at high levels on T-cells that become activated in people with the condition. Daclizumab modulates IL-2 signalling without causing general immune cell depletion.
According to the CHMP, trials have shown that Zinbryta can reduce the annualised relapse rate (ARR), as well as the risk of 24-week confirmed disability progression, and its most common side effects are elevations of liver enzymes and hepatic injury, cutaneous events, infections, gastrointestinal disorders and depression.
Elsewhere support also came for: Aptalis Pharma’s Enzepi (pancreas powder derived from porcine pancreatic glands) for the treatment of exocrine pancreatic insufficiency; and ITG Isotope Technologies’ EndolucinBeta (lutetium (177 lu) chloride), for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.
Also, GlaxoSmithKline’s (chlorhexidine digluconate), an antiseptic gel to prevent umbilical cord infections (omphalitis) in newborn babies, has been recommended by the Committee for use in countries outside the EU.
On the downside, a negative opinion was adopted for Proveca’s Sialanar (glycopyrronium bromide) as a treatment of persistent drooling in children and adolescents with neurological conditions. The CHMP noted that there was a lack of adequate data on the medicine’s risks as well as insufficient toxicology data from non-human studies.