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Lilly wins appeal for donanemab, drug to be reconsidered for NHS
Eli Lilly’s appeal against guidance which did not recommend donanemab has been upheld, forcing authorities to reconsider the drug for NHS use.
The National Institute for Health and Care Excellence (NICE) published the outcome for Lilly’s appeal, after final draft guidance had not recommended NHS reimbursement of donanemab for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease.
Donanemab is an amyloid-targeting treatment for people with mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
The decision means the final draft guidance will be returned to the relevant programme, and the committee will meet to consider estimates for infusion cost seen in the NHS and long-term data for donanemab.
“This is a big moment in the battle against Alzheimer’s disease,” Chris Stokes, General Manager of the Northern European Hub at Lilly, said in a statement.
“NICE was right to look again at the evidence in front of them and it’s welcome that our appeal has been upheld. For people living with Alzheimer’s disease, and for the families and carers who support them, this matters, perhaps now more than ever.
“We now look to NICE to use the flexibilities outlined in the manual, as it reassesses the evidence that Lilly, clinical experts and patient advocates have put forward, so that we can work towards our shared goal of ensuring all eligible patients with Alzheimer’s disease can access approved treatment options on the NHS as quickly as possible.”
The post Lilly wins appeal for donanemab, drug to be reconsidered for NHS appeared first on Drug Discovery World (DDW).
Can any of the new obesity medications in development stand out from the pack? Which company just broke records with its IPO? And will the Food and Drug Administration allow greater access to experimental peptides?
We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.
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RFK Jr. claims his calendar is publicly available. We’ve been trying to get it for a year
WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday pointed to his “publicly available calendar” as an example of his commitment to transparency and to beat back unfavorable reporting.
But no such calendar, detailing who Kennedy meets with or how he spends his time, has been released by the administration. STAT has been asking the Department of Health and Human Services for Kennedy’s calendar for more than a year, via Freedom of Information Act requests and emails to the press office.
WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday pointed to his “publicly available calendar” as an example of his commitment to transparency and to beat back unfavorable reporting.
But no such calendar, detailing who Kennedy meets with or how he spends his time, has been released by the administration. STAT has been asking the Department of Health and Human Services for Kennedy’s calendar for more than a year, via Freedom of Information Act requests and emails to the press office.
Uncategorized
Nonprofit buys experimental cancer drug to maintain patient access
In a rare move, nonprofit organization Blood Cancer United announced Thursday it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug.
As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, will also acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last.
In a rare move, nonprofit organization Blood Cancer United announced Thursday it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug.
As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, will also acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last.
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