US FDA approval tracker: October 2022

Several drugs got a grilling from the FDA in October, none more so than Covis’s Makena, which is used to reduce preterm birth risk. For a second time, an FDA panel recommended that Makena be removed from the market; the project received accelerated approval in 2011 but its confirmatory study failed in 2019. Now the FDA needs to follow through on its advice, with a final decision expected in the coming months. GSK’s Duvroq, a pill to manage anaemia in chronic kidney disease, had a mixed panel, being recommended for patients on dialysis but not for non-dialysis patients. On the approval front Johnson & Johnson gained a green light for Tecvayli in relapsed/refractory multiple myeloma, although the BCMA bispecific has a Rems program similar to Car-T therapies. Gilead, on the other hand, received a knockback for its hepatitis D project Hepcludex due to concerns over manufacturing and delivery. Gilead gained the project through its $1.4bn buyout of Myr two years ago. Meanwhile, Amicus will have to wait even longer for a decision on its Pompe disease candidate, which was delayed again by the FDA's inability to inspect a plant in China.

Notable first-time US approval decisions in October
Project Company Indication(s) 2028e sales by indication ($m) Outcome
Tecvayli (teclistamab) Johnson & Johnson R/r multiple myeloma  1,704 Approved (accelerated)
Hepcludex (bulevirtide) Gilead/ Hepatera Chronic hepatitis delta virus infection in adults with compensated liver disease 639 CRL (concerns regarding manufacture & delivery)
Cipaglucosidase for AT-GAA Amicus Pompe's disease 266* Deferred again (alongside second component miglustat; lack of manufacturing site inspection)
SPN-830 apomorphine infusion device Supernus Continuous treatment of motor fluctuations (off episodes) in Parkinson’s disease 198 CRL (infusion device issues, inspections)
Tislelizumab Beigene/
2nd-line oesophageal squamous cell carcinoma 83 Pending
Furoscix Scpharmaceuticals Congestion in patients with worsening heart failure - Approved
Imjudo (tremelimumab) + Imfinzi (Stride regimen) Astrazeneca Unresectable hepatocellular carcinoma  - Approved
*For AT-GAA product. Source: Evaluate Pharma & company releases.


Advisory committee meetings in October
Project Company Indication 2028e SBI ($m) Outcome
Duvroq (daprodustat) GSK Anaemia due to CKD in adults on/not on dialysis 355 13-3 in favour for patients on dialysis, 5-11 against in non-dialysis patients
Sohonos (palovarotene) Ipsen Prevention of heterotopic ossification in adults & children with fibrodysplasia ossificans progressiva 152 Postponed (FDA request for new information on clinical trial data)
Y-Mabs  Neuroblastoma with CNS/leptomeningeal metastases 69 16-0 against, not provided sufficient evidence to conclude that omburtamab improves OS
Makena Amag/ Covis Reducing risk of preterm birth in women who have a history of singleton spontaneous preterm birth - 14-1 that Makena was not effective, and that it should be removed from the market
Source: Evaluate Pharma, company releases & FDA adcom calendar.


Supplementary and other notable approval decisions in October
Product Company Indication (clinical trial) Outcome
Oxlumo Alnylam Reduction of plasma oxalate in advanced primary hyperoxaluria type 1 (Illuminate-C) Approved
Rinvoq Abbvie Non-radiographic axial SpA (Select-Axis 2 Study 2) Approved
Boostrix GSK Immunisation during third trimester to prevent pertussis (whooping cough) in infants under 2mths old Approved
Menveo GSK Single-vial presentation to prevent disease caused by meningococcal bacteria serogroups A, C, Y & W in individuals aged 10-55 Approved
mRNA-1273.222 (bivalent) Moderna Covid vaccine booster dose, down to six years of age EUA
Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine Pfizer/Biontech Covid vaccine booster dose, down to five years of age EUA
Novavax Covid-19 vaccine, adjuvanted (NVX-CoV2373) Novavax Covid vaccine booster dose, in adults aged 18 and over (Prevent-19, Cov-Boost) EUA
Source: Evaluate Pharma & company releases.

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