Go or no go? Roche’s fresh start for a new year

2022 kicks off with key FDA decisions for Roche, Novartis and Pfizer, while Astrazeneca hopes to extend Lynparza even further.

Christmas has come early for a handful of companies, with Astrazeneca and Amgen’s Tezspire and Argenx’s Vyvgart both scoring FDA approval last week. And a decision for Novartis’s Leqvio could also come before its New Year’s Day action date as the FDA tries to wrap up outstanding business by the holiday shutdown.

Roche too will be looking to start the year on a positive note with approval of faricimab, but it is unclear how much headway this bispecific antibody will make in an increasingly crowded wet age-related macular degeneration and diabetic macular oedema space. Regeneron and Bayer's Eylea is the big competition here, with Roche hoping to win share with faricimab's less frequent dosing.

The project has shown itself to be non-inferior to Eylea, but the Regeneron/Bayer drug starts to lose patent protection in 2023. Roche might not have long to exploit its advantage.

Regeneron and Bayer are not standing still, of course, with an 8mg dose of Eylea – the standard is 2mg – in pivotal trials that are due to yield data early next year. Add to this Byooviz, a biosimilar version of Lucentis that is already approved in wet AMD, and faricimab will have its work cut out.

Jaking up the pressure

Regulatory approval might only be the start of Pfizer’s worries for Cibinqo, a Jak inhibitor whose commercial prospects could be blighted by worries over class toxicity. Pfizer is aiming Cibinqo at the atopic dermatitis space, where Dupixent has a very strong hold; harsh label warnings for the Pfizer Jak would make it harder for the company to grab share. 

Approval came in Europe last week in AD, but the project is unlikely to escape the warnings the FDA applied to other recent approvals in the Jak inhibitor space

Finally, Astrazeneca/Merck & Co’s Lynparza could score a supplementary approval in adjuvant breast cancer, helping cement its reputation as a cancer powerhouse.

A positive decision would see Lynparza become the first Parp inhibitor approved for adjuvant use in breast cancer, based on impressive results of the Olympia trial, in which it reduced the risk of disease recurrence in patients with gBrca1/2 mutations, and generated a numerical overall survival benefit. 

Notable first-time US approval decisions due in January
Project Company Pdufa date Indication(s) 2026e sales by indication ($m) Note
Pfizer/Opko Est Jan Growth hormone deficiency 156 Delayed from October
Leqvio Novartis Jan 1 Hyperlipidaemia in adults who have elevated LDL-C while being on a maximum tolerated dose of a statin therapy 2,026 Could come by YE 2021 (Go or no go? Argenx's December showdown)
Recorlev Strongbridge/
Xeris Biopharma
Jan 1 Cushing's syndrome 255 Acquisition of Strongbridge by Xeris completed in Oct
Daridorexant Idorsia Est Jan 7 Insomnia 532 Idorsia claims second insomnia hit, but has it done enough?
Mycovia Jan 27 Recurrent vulvovaginal candidiasis - -
Faricimab Roche Est Jan 28 wAMD, DME 1,134 See text
Zonisamide oral suspension Azurity/Eton Jan 29 Partial seizures in patients with epilepsy - Manufacturing inspection still pending
Cibinqo Pfizer H1 Atopic dermatitis 1,035 See text
177Lu-PSMA-617  Novartis H1 Radioligand therapy for mCRPC 539 Asco 2021 justifies Novartis’s radioligand Vision
Source: Evaluate Pharma & company releases.


Supplementary and other notable approval decisions in January
Product Company Indication (clinical trial) Date
Cabenuva GSK HIV PrEP (HPTN 083, HPTN 084) Jan 24
Libtayo Regeneron Recurrent/met cervical cancer whose disease progressed on or after chemotherapy (Empower-Cervical 1/GOG-3016/ENGOT-cx9) Jan 30
Lynparza Astrazeneca Adjuvant Brca-mutated Her2-negative breast cancer (OlympiA) Q1
Fasenra Astrazeneca Nasal polyps H1
Source: Evaluate Pharma & company releases. 

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