France is set to become the first country in Europe to fund Imcivree for a second – and as yet unapproved – indication. Meanwhile, England has agreed to reimburse the drug for its approved indication as did Germany earlier this year. Reimbursement discussions are underway in the rest of Europe.

The US FDA is set for two high-profile advisory committee meetings on potential ALS treatments before the end of 2022. Whatever the outcome, they will fit a pattern: when it comes to ALS treatments, there is very little about the regulatory process that feels routine.

The European Medicines Agency has recommended new uses for six approved products, including the CAR T-cell therapy Tecartus. 

The US firm’s Imcivree has impressed with interim mid-stage data from a hypothalamic obesity study, paving the way for pivotal success that could open up a much larger market.