US FDA approval tracker: December 2021

After a tough 2021, Novartis finally caught a break with the approval of Leqvio, its long-awaited cholesterol-lowering therapy. With a list price of $6,500 per year, the drug is being pitched at around the same level as the incumbent PCSK9 MAbs; early sales could indicate whether the long-acting therapy can become Novartis’s biggest ever drug, as predicted by chief executive officer Vas Narasimhan. Meanwhile, both Leo Pharma and Astrazeneca/Amgen look set to have a tough time going up against Dupixent in different indications, with Adbry and Tezspire, respectively. Efficacy data with Adbry in atopic dermatitis did not impress, while Tezspire is approved for severe asthma, versus Dupixent’s moderate-to-severe label. Leerink analysts reckon that Tezspire will be initially reserved for low-eosinophil patients who cannot receive Dupixent or other asthma biologics, putting pre-approval sellside predictions in doubt. Merck & Co could also struggle to compete with its Covid-19 antiviral molnupiravir, which got an EUA the day after Pfizer’s Paxlovid; unlike molnu, the latter sailed through without an adcom. Molnu is destined to be a last-ditch option due to lacklustre efficacy plus concerns about potential foetal toxicity and the possibility that it could accelerate viral evolution.