The Good: Novartis (NVS -0.2%) division Alcon gets a thumbs up from the EMA's Committee for Medicinal Products for Human Use for Simbrinza eye drops suspension (brinzolamide 10mg/ml and brimonidine tartrate 2 mg/ml) to reduce intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. The product combines two medicines already approved for elevated IOP but simplifies the drop schedule and reduces the treatment burden.
The Bad: The Committee for Medicinal Products for Human Use adopts a negative opinion for the use of RLX030 (serelaxin) as a treatment for acute heart failure. This is the second thumbs down after January's negative opinion. The company plans to resubmit its application yet again after additional data become available.