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Novartis (NVS) Gets CRL From the FDA for Cholesterol Drug

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Novartis AG (NVS - Free Report) announced that the FDA has issued a complete response letter (CRL) regarding its new drug application (NDA) for cholesterol drug, inclisiran.

The company is seeking approval of the candidate for the potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy.

The regulatory body stated that it cannot approve the NDA by the scheduled target action date of Dec 23, 2020, due to unresolved facility inspection-related conditions. The conditions will be conveyed to the European manufacturing facility within 10 business days.

Nevertheless, the FDA has not raised any concerns related to the efficacy or safety of inclisiran.

No onsite inspection was conducted of the single third-party facility. If a facility inspection is required, the agency will define an approach once safe travel resumes, based on public health needs and other factors.

We remind investors that the candidate was recently granted marketing authorization by the European Commission under the brand name, Leqvio.

Inclisiran is the first and only small interfering RNA (siRNA) therapy to reduce LDL-C levels via an RNA interference (RNAi) mechanism of action and could help improve outcomes for patients with atherosclerotic cardiovascular disease (ASCVD).

Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals (ALNY - Free Report) .

The stock has lost 1.7% in the year so far against the industry’s growth of 6.8%.

Earlier, Bristol Myers Squibb (BMY - Free Report) too announced that the FDA has informed about a delay in the review of its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) as the agency was unable to conduct an inspection of a third-party manufacturing facility due to travel restrictions related to the COVID-19 pandemic.

Novartis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Repligen (RGEN - Free Report) , which sports a Zacks Rank #1 (Strong Buy), presently. You can see the complete list of today’s Zacks #1 Rank stocks here.

Repligen’s earnings per share estimates have moved up from $1.42 to $1.66 for 2021 in the past 60 days.

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