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Novartis: CHMP Confirms Negative Opinion For Serelaxin, Recommends Simbrinza

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Swiss drug giant Novartis AG (NVS: Quote) said Friday that health regulators in Europe have confirmed a negative opinion, recommending the refusal of marketing authorization for RLX030 or serelaxin intended for the treatment of acute heart failure or AHF.

Meanwhile, Novartis' eyecare unit Alcon received a positive opinion from European regulators, recommending marketing approval for Simbrinza, a new fixed-dose combination to treat patients with glaucoma.

Novartis noted that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency indicated that further evidence was required for a license to be granted for serelaxin in the European Union.

This follows Novartis' request for re-examination after a previous negative opinion for serelaxin was issued by the CHMP in January. At that time, Novartis said it will shortly submit a revised filing package to CHMP, including new data analyses, for re-examination for conditional marketing authorization of serelaxin.

When a pharmaceutical company applies for marketing authorization through the centralized authorization procedure, the CHMP gives a positive or negative recommendation in the form of a scientific opinion on whether a medicine should be authorized.

Novartis said Friday it plans to resubmit for approval as soon as additional data is available from the ongoing global trial program. This includes the 6,300 patient RELAX-AHF-2 study, one of the largest programs undertaken by a company for an AHF drug.

Tim Wright, Global Head of Development, Novartis Pharmaceuticals said, "We are disappointed that patients in Europe will not have access to RLX030 in 2014 but we believe in the value that RLX030 can bring to patients and are committed to extending the current evidence base to confirm this."

Heart failure is a debilitating and potentially life-threatening condition that affects more than 20 million people worldwide and costs the world economy $45 billion annually. In heart failure, the heart cannot pump enough blood around the body. In most cases, this happens because the heart muscle responsible for the pumping action weakens over time or becomes too stiff.

Novartis said it is committed to research in heart failure with a portfolio that includes RLX030 for acute heart failure and LCZ696 for chronic heart failure.

Meanwhile, the CHMP has issued a positive opinion for Alcon's Simbrinza eye drops suspension to decrease elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, for whom monotherapy does not provide sufficient reduction of intraocular pressure or IOP.

A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission or EC. The EC generally follows the recommendations of the CHMP and delivers its final decision within three months, which will be applicable to all European Union or EU, and European Economic Area or EEA countries.

Simbrinza combines two medicines that have already been approved for the treatment of elevated IOP into one multi-dose bottle, to be dosed with one drop into the affected eye twice daily.

Fort Worth, Texas-based Alcon noted that if approved, this fixed-dose combination therapy will offer a simplified eye drop schedule and reduce the treatment burden for patients suffering from open-angle glaucoma or ocular hypertension.

Jeff George, Division Head of Alcon said, "We are pleased by the positive CHMP opinion for Simbrinza Glaucoma is a progressive eye disease that must be treated every day over the course of a patient's life. By combining two therapies in one, Simbrinza will help patients to effectively manage high eye pressure, with a simple dosing regimen."

The CHMP opinion was based on two pivotal end-stage clinical trials for evaluating the safety and efficacy of Simbrinza administered twice daily. Results showed that IOP reductions from baseline with Simbrinza were 25 percent to 37 percent in glaucoma patients, thus providing strong efficacy with sustained IOP control throughout the day. Simbrinza is the only fixed-dose combination therapy available to lower IOP that does not contain beta blockers.

Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve and can result in gradual, irreversible loss of vision and eventually blindness. It is the second cause of irreversible blindness after cataract and affects more than 60 million people worldwide. There is no cure for glaucoma and vision lost cannot be restored.

Medications can lower eye pressure, the only known modifiable risk factor for glaucoma, but must be taken life-long and regularly. The exact cause of glaucoma is unknown.

NVS closed Thursday's trading at $89.98, up $0.49 on a volume of 4.14 million shares.

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by RTT Staff Writer

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