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Last week, Novartis was touting positive data showing its repurposed leukemia drug ofatumumab outpaced Sanofi’s Aubagio in a multiple sclerosis trial. Now, Novartis has revealed that the FDA, which was supposed to hand down a verdict on the drug this month, needs until September to make the decision.

What happened? Novartis isn’t saying much.

Novartis will “continue to work with the FDA” to complete the review and is ready to launch the drug—already on the market as Arzerra in leukemia—upon approval, Marie-France Tschudin, president of Novartis Pharmaceuticals, said in a brief statement. Novartis told FiercePharma the FDA extended the review “based on a company submission in response to routine review questions,” but that it’s confident it has the data needed to complete the review.

Considering how competitive the MS market has become of late, it will be tough for Novartis to put a positive spin on the FDA delay. The company’s MS drugs Mayzent and Gilenya are now facing fresh competition from Bristol Myers’ Squibb, which launched its rival MS drug Zeposia earlier this week.

Those drugs are S1P modulators, while ofatumumab targets CD20-expressing B cells. But Novartis is facing competition in that class of medicines, too, not only from Aubagio but also from Roche behemoth Ocrevus.

During Novartis’ first-quarter earnings conference call, one analyst worried that the FDA hadn’t completed needed inspections of ofatumumab manufacturing sites, including one in China. The company’s executives played down the concerns.

The FDA “has stayed committed to their view that they can meet their PDUFA timelines, and they will be using technology, virtual inspections, paper inspections, et cetera,” CEO Vasant Narasimhan said at the time.

Novartis’ manufacturing site in Switzerland was inspected a year ago, chief medical officer John Tsai added, but “we’ve not heard anything else in terms of the current inspection,” he said.

Analysts had high hopes for Novartis’ ability to compete in the market for B-cell targeted MS drugs, largely because of the strong head-to-head data the company has produced. During the virtual Congress of the European Academy of Neurology in late May, the company unveiled that in late-stage trials, 47% of patients taking its drug showed no evidence of disease within a year, while that milestone was reached by just 24% of those taking Aubagio.

Novartis had also planned to play up ofatumumab’s convenience: It’s a once-monthly injection that patients can give themselves, while Aubagio is a daily pill and Ocrevus is an IV infusion.

Novartis’ executives were so confident the dosing schedule would be a key selling point that they had planned to launch ofatumumab during the COVID-19 shutdowns—even though patients would need to be taught how to inject the product. When an analyst asked about that during Novartis’ first-quarter earnings call, Tschudin said “it can be done by the observation of a healthcare professional. So technically, we could be sending nurses” to patients’ homes.

As lockdowns ease across the country, the need to send nurses to MS patients’ homes may be less of a worry for Novartis if ofatumumab does finally get the green light from the FDA in September. But the competition isn’t going away, and Novartis was preparing a full-out attack by boosting its investment in the drug prior to its launch.

“We’re ready for whatever the situation is when we launch, whether we’re seeing prescribers or other stakeholders face to face or virtually on a state-by-state basis,” Tschudin said during the call. The goal, she added, “is that when patients come back, we’ll make it easy for them to start on ofatumumab.”

By: Arlene Weintraub

Source: Fierce Pharma