Landiolol

Unassigned

New Medicines

Rapibloc · Supraventricular tachycardia, rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter, and non-compensatory sinus tachycardia

Information

Rapibloc
New molecular entity
AOP Orphan Pharmaceuticals AG
Ennogen Healthcare

Development and Regulatory status

None
Launched
None
Aug 20 · Proposed indication is treatment of supraventricular tachycardia and for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the ventricular rate with a short acting agent is desirable. Also Non-compensatory sinus tachycardia where, in the physician judgement the rapid heart rate requires specific intervention [6].
Aug 20 · AOP Orphan is planning to file for a UK licence using the EU decentralised procedure [6].
Feb 18 · AOP Orphan will not disclose their UK launch plans at this time [5].
Jun 17 · AOP Orphan Pharmaceuticals AG has previously signed a commercialisation agreement with AMOMED Pharma, whereby AMOMED regional subsidiaries in the EU will exclusively commercialise landiolol. AMOMED is also entitled to distribution rights in selected regions outside the EU, except USA and Canada [4].
Jun 17 · Launched in Austria and Germany as Rapibloc 300mg powder for solution for infusion [4].
Jul 16 · Approved in EU via decentralised procedure, for treatment of arrhythmias, including atrial fibrillation and atrial flutter. The company intends to launch landiolol in Q1/2 2017[1].

Category

Ultra short acting β1-superselective beta-blocker. Available as 300mg and 600mg vials.
Arrhythmias or heart rhythm problems are experienced by more than 2 million people a year in the UK [3].
Supraventricular tachycardia, rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter, and non-compensatory sinus tachycardia
Intravenous infusion

Trial or other data

Aug 20 · Landiolol was developed by modifying the chemical structure of esmolol to produce a compound with a higher rate of cardioselectivity and a greater potency without increasing its duration of action. In comparison to other betablockers, landiolol has the shortest elimination half-life (3 to 4 minutes), ultra-rapid onset of effect (heart rate begins to decrease immediately after completion of administration), and predictable effectiveness with inactive metabolites (heart rate returns to baseline levels at 30 min after completion of landiolol hydrochloride administration). The pure S-enantiomer structure of landiolol is believed to develop less hypotensive side effects in comparison to other β-blockers. The company expects landiolol will be used in a small sub set of ICU patients per year, or postoperative patients developing severe tachyarrhythmia, instead of esmolol [6].
Dec 19 · PIII trial (NCT03779178) completes [7].
Jan 19 · PIII trial to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo starts (NCT03779178). 58 adults will be recruited in France. Primary outcome is Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS) at 20/40/60/80/100/120 minutes after administration; collection of these data is due to complete Dec 19 [7]
Mar 16 · AOP Orphan Pharmaceuticals completed a phase II trial evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of landiolol in elderly Caucasian patients with tachycardic atrial fibrillation or flutter (EudraCT2014-001905-42) [1].