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FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic
12 March 2019
The U.S. Food and Drug Administration has approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of…
New indication for Dupixent (dupilumab) as add on treatment for patients with severe asthma
4 March 2019
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication to Dupixent (dupilumab) as an add-on maintenance treatment for adult and adolescent (12 years and older) patients with certain forms of severe asthma. Asthma is a chronic lung disease caused by the…
Ondexxya (andexanet alfa), first antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban
4 March 2019
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ondexxya (andexanet alfa). This medicine is to be used as an antidote for adult patients taking the anticoagulant (clot-preventing) medicines apixaban or rivaroxaban,…
Waylivra (volanesorsen), first treatment for rare disease characterised by high levels of triglycerides in blood
4 March 2019
The European Medicines Agency has recommended granting a conditional marketing authorisation (CMA) for Waylivra (volanesorsen), the first medicine for the treatment of the familial chylomicronaemia syndrome (FCS). FCS is a rare genetic disease that prevents the body from breaking down fats…
Palynziq (pegvaliase), new treatment for phenylketonuria, a rare inherited metabolic disease
4 March 2019
EMA’s human medicines committee (CHMP) has recommended the authorisation of Palynziq (pegvaliase), a new medicine for patients aged 16 and older with phenylketonuria, a rare but potentially serious inherited metabolic disease. Patients suffering from this disorder do not have the enzyme that…
Zynquista (sotagliflozin), New add-on treatment to insulin for treatment of certain patients with type 1 diabetes
4 March 2019
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Zynquista (sotagliflozin) intended as an adjunct to insulin for certain patients with type 1 diabetes mellitus. Zynquista is a small molecule with dual inhibitor activity on SGLT1 and SGLT2. It works in the kidneys to…
The World Health Organisation issues an alert on falsified ICLUSIG traded globally
18 February 2019
The Medical Product Alert relates to confirmed falsified versions of ICLUSIG 15mg and ICLUSIG 45mg circulating in the WHO Region of Europe and the WHO Region of the Americas. Genuine ICLUSIG, the active pharmaceutical ingredient of which is Ponatinib Hydrochloride, is used to treat different forms…
Forxiga and Edistride (Dapagliflozin) recommended by EMA as first oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes
10 February 2019
EMA’s human medicines committee (CHMP) has recommended for the first time an adjunct treatment to insulin in the form of a tablet for certain patients with type 1 diabetes mellitus. Dapagliflozin is already authorised in the European Union as Forxiga and Edistride for the treatment of patients with…
Cablivi (caplacizumab-yhdp) approved by FDA for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP)
7 February 2019
The U.S. Food and Drug Administration has approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare…