Novartis set to answer inclisiran's FDA rebuff by Q3. But what about an approval timeline?

Novartis bought cholesterol drug inclisiran on the brink of a new drug filing as the centerpiece of its $9.7 billion acquisition of The Medicines Company. But, in the wake of an FDA rebuff amid the pandemic, the Swiss pharma’s now unsure when it might roll out the potential blockbuster in the U.S.

Novartis is targeting the second or third quarter for its reply to the complete response letter the FDA slapped on inclisiran’s application in late 2020, the company said.

After that, the timeline is unpredictable, Novartis CEO Vas Narasimhan, M.D., told reporters Tuesday.

Back in December, Novartis characterized the FDA's problem as “unresolved facility inspection-related conditions” at an Italian plant that belongs to its collaborator Corden Pharma. On Tuesday’s call with reporters, Narasimhan further labeled the hiccup as “primarily related to process control-related issues” and stressed that it has nothing to do with inclisiran’s efficacy, safety or manufacturing techniques.

On-site inspection of the Italian facility was originally planned for May 2020, but, due to the pandemic, it was turned into a paper-based inspection, Narasimhan explained.

RELATED: FDA rebuffs Novartis' cholesterol drug inclisiran in an 'inspection-related' approval delay

Novartis is now working with its partner to resolve questions the FDA raised in its CRL. “Beyond that, it’s difficult to predict,” Narasimhan said. “In the end, it’s the FDA’s decision whether or not they want to inspect the facility and when they would be willing to go back to Europe to inspect such a facility. So it’s difficult to comment on the timeline from there.”

As the fate of the Italian facility hangs in the balance, Novartis is working on transferring the inclisiran manufacturing process to a Novartis-owned facility as an option for the medium term, Narasimhan added.

Novartis has high hopes for this PCSK9 drug, which it essentially paid $9.7 billion for. Analysts at Evaluate Pharma recently pegged its 2026 sales at $2 billion.

A few days before its FDA woe surfaced, the drug had won EU approval under the brand Leqvio. Novartis now expects the drug's first prescriptions to be filled in Germany in February, and it’s initially targeting patients at high risk of cardiovascular disease.

RELATED: Novartis' $9.7B MedCo buyout bears first fruit as blockbuster-to-be inclisiran nabs EU nod

Meanwhile, the company has a broad access agreement with the U.K. government to tackle what Novartis' pharma president Marie-France Tschudin called “nonclinical barriers” ahead of Leqvio.

Currently, patients with high bad cholesterol levels aren’t sticking to their treatments. About a year after they get prescribed statins, nearly 80% of patients are off therapy, Tschudin said on the call. “We have an opportunity with this medicine that is given twice a year and administered by a physician to really tackle the problem of adherence,” she said.

The U.K. program is expected to launch in the third quarter, pending National Health Service coverage backing from the National Institute for Health and Care Excellence.