Berliner Boersenzeitung - Highly awaited Alzheimer's drug hit by delays

EUR -
AED 3.898523
AFN 71.644005
ALL 97.648604
AMD 411.303772
ANG 1.914021
AOA 969.589347
ARS 1059.019177
AUD 1.626695
AWG 1.912116
AZN 1.80447
BAM 1.955933
BBD 2.144347
BDT 126.914629
BGN 1.954472
BHD 0.400029
BIF 3075.943987
BMD 1.061402
BND 1.421364
BOB 7.364849
BRL 6.103346
BSD 1.062022
BTN 89.684337
BWP 14.448665
BYN 3.475501
BYR 20803.485902
BZD 2.140647
CAD 1.480529
CDF 3045.163175
CHF 0.936725
CLF 0.037924
CLP 1046.446944
CNY 7.676591
COP 4708.91149
CRC 543.462642
CUC 1.061402
CUP 28.127162
CVE 110.75745
CZK 25.388317
DJF 188.63237
DKK 7.459344
DOP 63.949359
DZD 141.630617
EGP 52.228957
ETB 129.544535
FJD 2.403068
GBP 0.83336
GEL 2.907944
GHS 17.422944
GMD 75.88837
GNF 9160.963762
GTQ 8.206946
GYD 222.173049
HKD 8.255656
HNL 26.609498
HTG 139.686101
HUF 410.858482
IDR 16798.071884
ILS 3.986711
INR 89.576785
IQD 1389.00842
IRR 44690.345182
ISK 147.502873
JMD 168.751502
JOD 0.752638
JPY 164.256789
KES 137.455129
KGS 91.487137
KHR 4303.986593
KMF 488.643096
KRW 1496.142353
KWD 0.326385
KYD 0.885002
KZT 527.030748
LAK 23308.395923
LBP 95101.650121
LKR 310.555796
LRD 196.730493
LSL 19.220988
LTL 3.134045
LVL 0.642031
LYD 5.1637
MAD 10.530204
MDL 19.010191
MGA 4935.52124
MKD 61.5696
MMK 3447.393404
MOP 8.50898
MRU 42.348517
MUR 50.002527
MVR 16.409566
MWK 1841.533028
MXN 21.879534
MYR 4.710487
MZN 67.850153
NAD 19.221764
NGN 1775.386729
NIO 39.027305
NOK 11.770703
NPR 143.49454
NZD 1.792862
OMR 0.408655
PAB 1.062022
PEN 4.021622
PGK 4.261796
PHP 62.358462
PKR 295.01699
PLN 4.35371
PYG 8297.565537
QAR 3.864301
RON 4.975817
RSD 116.983541
RUB 104.280832
RWF 1449.875599
SAR 3.988118
SBD 8.864043
SCR 14.393167
SDG 638.433911
SEK 11.579719
SGD 1.421722
SLE 24.195333
SOS 606.572528
SRD 37.398523
STD 21968.885515
SVC 9.293071
SZL 19.221951
THB 37.033402
TJS 11.288563
TMT 3.714908
TND 3.340765
TOP 2.485908
TRY 36.491299
TTD 7.216832
TWD 34.42106
TZS 2825.309757
UAH 43.984498
UGX 3902.449814
USD 1.061402
UYU 44.775161
UZS 13601.870796
VES 47.628304
VND 26906.549368
XAF 656.032617
XCD 2.868493
XDR 0.800092
XOF 652.762858
XPF 119.331742
YER 265.111791
ZAR 19.232187
ZMK 9553.893659
ZMW 28.913333
ZWL 341.771121
  • RBGPF

    0.0300

    60.22

    +0.05%

  • SCS

    0.0200

    13.67

    +0.15%

  • NGG

    -1.2400

    62.9

    -1.97%

  • CMSC

    -0.1800

    24.54

    -0.73%

  • RELX

    -1.2100

    46.59

    -2.6%

  • AZN

    0.4000

    65.19

    +0.61%

  • RIO

    -1.4000

    61.2

    -2.29%

  • BTI

    0.0900

    35.24

    +0.26%

  • RYCEF

    -0.1700

    7.16

    -2.37%

  • CMSD

    -0.2100

    24.75

    -0.85%

  • GSK

    -0.8300

    35.52

    -2.34%

  • BCC

    -2.0100

    141.13

    -1.42%

  • BCE

    -0.1600

    27.69

    -0.58%

  • JRI

    -0.3000

    13.22

    -2.27%

  • VOD

    -0.8500

    8.47

    -10.04%

  • BP

    -0.7600

    28.16

    -2.7%

Highly awaited Alzheimer's drug hit by delays
Highly awaited Alzheimer's drug hit by delays / Photo: PHILIPPE LOPEZ - AFP

Highly awaited Alzheimer's drug hit by delays

Eli Lilly's highly anticipated Alzheimer's drug has been held back for further review by regulators, the US pharmaceutical giant said Friday, in a blow for patients with the devastating brain disorder.

Text size:

Donanemab has been found to slow cognitive decline in the early stages of the disease during a clinical trial -- but there was also a high rate of side effects, including deaths.

The Food and Drug Administration (FDA) "has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab," the company said in a statement Friday.

The regulator told the Indiana-based company it would convene a new meeting of experts, but hadn't provided a firm date. "As a result, the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024."

"We are confident in donanemab's potential to offer very meaningful benefits to people with early symptomatic Alzheimer's disease," said Anne White, the company's executive vice president.

She added the FDA's decision to have a new meeting was "unexpected," but "We will work with the FDA and the stakeholders in the community to make that presentation and answer all questions."

Donanemab is an intravenously injected antibody that targets the build up beta-amyloid, a protein found in the brains of many patients with Alzheimer's.

Another anti-amyloid therapy called Leqembi, which was developed by Eisai of Japan and Biogen of Massachusetts, was granted full approval by the FDA last July and is now accessible through government-run health insurance for the elderly called Medicare.

- Slows decline, but risky -

In a paper published in the Journal of the American Medical Association last year, researchers found donanemab slowed cognitive and functional decline in patients who have early symptoms of the disease.

Forty-seven percent of those who received the drug showed no signs of cognitive decline after one year of treatment, compared to 29 percent who received a placebo.

Serious adverse events, including brain bleeds, occurred in 17.4 percent of those who received donanemab and 15.8 percent of those who received a placebo.

There were also four deaths: three in the donanemab group and one in the placebo group, but all the fatalities were considered a result of the treatment they received.

The trial recruited participants aged 60 to 85 with early symptomatic Alzheimer's, either mild cognitive impairment or Alzheimer's disease with mild dementia.

The news comes after the first Alzheimer's drug to be approved was pulled from the market in January.

The FDA awarded accelerated approval to Aduhelm in June 2021, a decision that was contentious at the time because the agency overruled its own independent advisors, who found there was insufficient evidence of benefit.

Biogen, which co-developed Aduhelm with Eisai, said it was discontinuing Aduhelm to focus its efforts of Leqembi.

Alzheimer's is the most common form of dementia. More than one in nine people over 65 develop the condition, which worsens over time, robbing them of their memories and independence, according to the US Alzheimer's Association.

(Y.Yildiz--BBZ)