Go or no go? Sanofi’s Cablivi leads February’s approvals charge

Others in the FDA queue include Bausch’s psoriasis therapy Duobrii and Motif Bio’s antibiotic Iclaprim.

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Yesterday’s US approval of Sanofi’s rare disease project Cablivi (caplacizumab) goes some way to justifying the group’s €3.9bn ($4.4bn) purchase of Ablynx.

Other companies will be hoping for similarly good news as the agency gets back to full strength after the end of the US government shutdown. But, with the threat of another closure looming on February 15, biopharma groups might be scrambling to file their projects before this deadline.

Of course, the last shutdown stopped the FDA from accepting new submissions but did not put the brakes on drug approvals. And the Cablivi nod came on its PDUFA date, suggesting that drug reviews have not yet begun to suffer from the effects of the shutdown.

The Sanofi drug is now approved broadly for patients with acquired thrombotic thrombocytopenic purpura, with no requirement for the disease to be confirmed via a diagnostic test – something that might have been expected given previous uncertainty about diagnosis (Ash 2017 – Herculean effort scores Ablynx a late-breaker, December 13, 2017).

This should cheer Sanofi: with EvaluatePharma sellside consensus forecasting 2024 Cablivi revenues of $627m, the drug is one of the group’s biggest pipeline hopes, although this figure looks optimistic – a failure to meet this would make the deal look even more expensive. And the French group also announced today that it had abandoned another Ablynx-originated asset, ALX0171 (Sanofi does a spring clean, February 7, 2019).

Other groups awaiting US approval decisions this month include Bausch Health, which could get the go-ahead for two projects, the psoriasis lotion Duobrii and its 0.38% loteprednol etabonate ophthalmic gel for post-operative inflammation and pain following ocular surgery.

Notable February first-time approval decisions
Project Company PDUFA date Product NPV ($m)
Cablivi Sanofi Feb 6 2,318
Iclaprim Motif Bio Feb 13 743
Duobrii Bausch Health Feb 13 153
Loteprednol etabonate ophthalmic gel Bausch Health Feb 25 n/a

The FDA already knocked Duobrii back once before, and Bausch will have to hope that it has answered the agency’s questions on pharmacokinetics. The new ocular gel, meanwhile, could extend the company’s existing loteprednol franchise beyond Lotemax, a gel containing the same steroid.

The new gel has a lower dose and is also given less frequently, although there is not much in it: Lotemax is administered four times per day, while the new formulation has been tested two or three times daily.

The other first-time approval decision expected in February involves Motif Bio’s lead project, the antibiotic iclaprim, which is awaiting the nod for its first indication, acute bacterial skin and skin structure infections. A thumbs up would be a coup for Motif, which was only founded in 2014 – but the question of how to make money out of antibiotics is still open.


Meanwhile, various projects are awaiting decisions on label expansions. Johnson & Johnson and Genmab could soon see the initial dose of their multiple myeloma therapy Darzalex split over two days to improve patient convenience.

Merck & Co’s Keytruda could join Bristol-Myers Squibb’s rival PD-1-targeting drug Opdivo in the adjuvant melanoma setting. And Pfizer is still awaiting a decision on its Herceptin biosimilar PF-05280014.

Supplementary approvals and other notable regulatory decisions for February
Product Company Event type Date
Darzalex Johnson & Johnson/
sBLA for split dosing regimen for multiple myeloma Feb 8
Keytruda Merck & Co sNDA/BLA for adjuvant therapy for stage III melanoma Feb 15
Lonsurf Otsuka sNDA/BLA for metastatic gastric/gastroesophageal junction adenocarcinoma Feb 22
PF-05280014 Pfizer BSUFA on resubmission of Herceptin biosimilar for breast cancer Q1 2019

This year’s discussion of upcoming FDA approvals has largely concerned worries that a prolonged shutdown could lead to a shortage of funds and staff, and stop the agency from being able to approve new drugs.

Such fears have been assuaged for now. But, with President Donald Trump threatening another shutdown next week if his border wall is not funded, this issue could soon rear its head again.

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