AIRLINK 86.21 Decreased By ▼ -0.99 (-1.14%)
BOP 4.97 Decreased By ▼ -0.05 (-1%)
CNERGY 4.08 Decreased By ▼ -0.01 (-0.24%)
DFML 37.22 Decreased By ▼ -0.68 (-1.79%)
DGKC 91.20 Decreased By ▼ -2.68 (-2.85%)
FCCL 22.99 Decreased By ▼ -0.78 (-3.28%)
FFBL 33.74 Increased By ▲ 1.07 (3.28%)
FFL 9.19 Decreased By ▼ -0.06 (-0.65%)
GGL 10.05 Increased By ▲ 0.02 (0.2%)
HASCOL 6.25 Decreased By ▼ -0.29 (-4.43%)
HBL 126.25 Increased By ▲ 4.33 (3.55%)
HUBC 158.29 Increased By ▲ 12.64 (8.68%)
HUMNL 11.08 Increased By ▲ 0.58 (5.52%)
KEL 4.64 Decreased By ▼ -0.10 (-2.11%)
KOSM 4.09 Decreased By ▼ -0.10 (-2.39%)
MLCF 38.25 Decreased By ▼ -0.55 (-1.42%)
OGDC 133.40 Decreased By ▼ -1.61 (-1.19%)
PAEL 25.40 Increased By ▲ 0.32 (1.28%)
PIBTL 6.22 Decreased By ▼ -0.05 (-0.8%)
PPL 119.25 Decreased By ▼ -0.43 (-0.36%)
PRL 24.58 Increased By ▲ 0.48 (1.99%)
PTC 12.28 Increased By ▲ 0.06 (0.49%)
SEARL 59.32 Decreased By ▼ -0.48 (-0.8%)
SNGP 65.60 Increased By ▲ 0.60 (0.92%)
SSGC 9.87 Decreased By ▼ -0.18 (-1.79%)
TELE 7.85 Decreased By ▼ -0.02 (-0.25%)
TPLP 9.49 Decreased By ▼ -0.25 (-2.57%)
TRG 63.80 Decreased By ▼ -0.50 (-0.78%)
UNITY 27.26 Increased By ▲ 0.21 (0.78%)
WTL 1.28 Decreased By ▼ -0.04 (-3.03%)
BR100 8,341 Increased By 31.1 (0.37%)
BR30 26,457 Increased By 506.8 (1.95%)
KSE100 78,810 Increased By 9 (0.01%)
KSE30 25,474 Increased By 35.6 (0.14%)
Business & Finance

US FDA extends review period for Biogen's Alzheimer's drug

  • Our key takeaway is that if the FDA would have wanted to reject the drug, we would have heard the decision by now.
  • The road to getting a regulatory nod for the drug has been rocky, with the companies scrapping two studies of the therapy in March 2019, and reversing that decision a few months later.
Published January 29, 2021

Biogen Inc and partner Eisai Co Ltd said on Friday the US Food and Drug Administration has extended the review period for their experimental Alzheimer's disease treatment by three months.

Biogen's shares rose 8% premarket as the FDA extension raised some hopes that the drug may still be approved, after a panel of experts to the FDA voted against the drug in November.

"Our key takeaway is that if the FDA would have wanted to reject the drug, we would have heard the decision by now," said Truist analyst Robyn Karnauskas.

An FDA approval would make the drug, aducanumab, the first new treatment for Alzheimer's in decades and the first that appears to be able to slow progression of the fatal, mind-wasting condition that affects millions of people.

The road to getting a regulatory nod for the drug has been rocky, with the companies scrapping two studies of the therapy in March 2019, and reversing that decision a few months later.

The expert panel to the FDA had voted "no" to three questions related to whether a single successful large trial of aducanumab was enough evidence of the drug's effectiveness given the clear failure of a second large study.

The FDA is not obligated to follow the recommendations of the panel, but usually does.

The agency will now decide on the marketing application for aducanumab by June 7. Biogen submitted the drug's marketing application to the FDA in July 2020.

Comments

Comments are closed.