Novartis Reports Data on Inclisiran, CHMP Positive on Zolgensma

Novartis AG NVS has announced encouraging results from a prespecified analysis of pooled data from three phase III studies evaluating the safety and efficacy of inclisiran, its first-in-class experimental candidate for the treatment of hyperlipidemia in adults.

The prespecified analysis of pooled data from ORION-9, -10 and -11 phase III studies shows inclisiran reduced low-density lipoprotein-cholesterol (LDL-C) by 51% in 17 months.  In addition, the prespecified exploratory analysis showed fewer major adverse cardiovascular events (MACE) with inclisiran compared to placebo based on safety reporting from the three studies.

We note that inclisiran is currently under review by the FDA and European Medicines Agency (EMA) for use in adults with ASCVD or heterozygous familial hypercholesterolemia (HeFH), who have elevated LDL-C while being on a maximum tolerated dose of a LLT.

Separately, Novartis also announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion for spondylitis drug Cosentyx (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

The positive CHMP opinion of Cosentyx for nr-axSpA was based on efficacy and safety outcomes from the PREVENT phase III study, which included 555 adults with active nr-axSpA, with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults, who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

The CHMP also adopted a positive opinion recommending conditional marketing authorization of one-time administered gene therapy Zolgensma for patients with spinal muscular atrophy (SMA) and a clinical diagnosis of Type 1 or SMA patients with up to three copies of the SMN2 gene. Zolgensma has demonstrated significant and clinically meaningful therapeutic benefit in presymptomatic and symptomatic SMA, including prolonged event-free survival and achievement of motor milestones.

A potential label expansion of approved drugs bode well for Novartis and will likely rake in more sales.

Novartis was in news last week, after it announced that the company will provide up to 130 million doses of generic hydroxychloroquine to support the treatment of the global COVID-19 pandemic.

The donation comes at a time when countries all over the world are grappling with the spread of this deadly virus.

Notably, hydroxychloroquine and a related drug, chloroquine are being evaluated in studies for the treatment of coronavirus. Chloroquine is already approved for treating malaria, lupus and rheumatoid arthritis. Studies are underway to determine the efficacy of using chloroquine to treat COVID-19.

Novartis plans to donate up to 130 million 200 mg doses by the end of this May, including its current stock of 50 million 200 mg doses, for use in COVID-19 patients, supported by regulatory authorities. Novartis is also looking to ramp up its capacity to increase supply to meet the global demad.

Other companies like Teva Pharmaceutical Industries Ltd. TEVA also announced the immediate donation of more than 6 million doses of hydroxychloroquine sulfate tablets.

Mylan N. V. MYL too restarted production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility in the United States to meet the expected increased demand, resulting from potential effectiveness of the product in treating COVID-19.

Novartis’ shares have lost 14.8% in the past year compared with the industry’s decline of 10.3%.

Reportedly, Novartis’ oncology drug Jakavi, multiple sclerosis drug, Gilenya, and fever drug Ilaris are being studied for their effect on complications related to COVID-19.

Roche RHHBY has also received the FDA’s nod to conduct a double-blind, placebo-controlled phase III study to evaluate the safety and efficacy of intravenous rheumatoid arthritis (RA) drug, Actemra (tocilizumab), plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.

Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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