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CHMP nod for Alexion, GSK drugs, revocation for Lartruvo

Opioid dependence therapy and Pfizer's PARP inhibitor also recommended


The European Medicines Agency’s key committee has unveiled its ruling on the latest set of new medicines.

The CHMP recommended 13 medicines last Friday, including Ultomiris, Alexion’s follow-up to its rare disease blockbuster Soliris, and GSK’s single pill, two-drug HIV regimen, Dovato.

Ultomiris is very significant for Alexion, as it is bracing for the patent expiry of Soliris (eculizumab), used to treat paroxysmal nocturnal haemoglobinuria (PNH) and myasthenia gravis, and which hit revenues of around $3bn in 2018.

A second-generation PNH therapy, Ultomiris has matched Soliris’ efficacy with a trend towards superiority and improved dosing. It gained earlier than expected FDA approval on 21 December, and analysts predict sales of around $5bn by 2022.

Meanwhile, Dovato (dolutegravir/lamivudine) developed by GSK-led joint venture ViiV, is the first ever once-a-day two-drug STR for treatment-naïve patients.

By giving patients a simpler regimen containing fewer drugs, the expectation is that long term management of the condition will be easier, with patients less likely to develop side-effects. The drug is a vital new weapon for the company in its intense rivalry with Gilead in the HIV market.

The CHMP’s recommendations are usually the precursor to a full approval from the European Commission, normally within 6-8 weeks.

Other drugs gaining recommendation included:

Molteni Farmaceutici’s Sixmo (buprenorphine) an opioid dependence implant treatment that releases low levels of buprenorphine into the patient’s body for six months.

Novo Nordisk’s haemophilia A treatment Esperoct (turoctocog alfa pegol), a longer-acting extended half-life factor VIII molecule, which allows patients to inject themselves once every four days, rather than more frequent administration needed for standard therapy.

Dova Pharma’s Doptelet (avatrombopag) for the treatment of severe thrombocytopenia.

Conditional marketing authorisation for Sanofi’s PD-1 checkpoint inhibitor Libtayo (cemiplimab), for advanced cutaneous squamous cell carcinoma.

Nuceiva (botulinum toxin type a), a facial filler for vertical lines between the eyebrows, a new rival for Allergan’s Botox.

Pfizer’s Talzenna (talazoparib), a new contender in the PARP inhibitor class, for adult patients with germline BRCA1/2 mutations with HER2-negative locally advanced or metastatic breast cancer.

Authorisation revoked for Lartruvo

Friday’s ruling was also notable for the CHMP’s decision to revoke the marketing authorisation for Eli Lilly’s sarcoma treatment Lartruvo, after the drug failed to demonstrate its efficacy over standard treatment in a post-marketing study.

The recommendation, if approved, takes the EMA’s actions one stage further against the treatment, after calling for a block on prescribing of the treatment to any new patients back in January.

This action puts it ahead of the FDA for a second time, the US agency following two days after the EMA’s lead in calling for a suspension of new prescriptions.

Article by
Andrew McConaghie

28th April 2019

From: Regulatory



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