FDA rejects Teva's Azilect to delay Parkinson's

Teva sought to expand the use of its drug to delay the progression of Parkinson's disease. rather than just treat the symptoms.

"Reuters" reports that a US Food and Drug Administration (FDA) expert advisory panel yesterday rejected the use of Teva Pharmaceutical Industries Ltd's (Nasdaq: TEVA; TASE: TEVA) Azilect drug to delay the clinical progression of Parkinson's disease. The unanimous vote was based on researchers' findings. Azilect is currently used to treat the symptoms of Parkinson's disease, including trembling limbs, stiffness, slow movement and impaired balance. Teva was the first company to seek FDA approval for a drug to treat the progression of the neurogenetic disease, rather than just its symptoms.

"This is really going to be the flagship... and we have to be very solid in this and set a very high standard," said panelist Dr. Robert Clancy a neurology professor at the Children's Hospital of Philadelphia. "If we're wishy-washy with this, then the next thing that comes around is going to be expecting that being close is good enough. And this is close, but it's not good enough."

Teva jointly markets Azilect with Danish drug company H. Lundbeck A/S (OMX: LUN).

Teva's share price rose 0.3% on Nasdaq yesterday, bucking the market, to $39.29, giving a market cap of $35 billion. The share price fell 0.6% in early trading on the TASE today to NIS143.20.

Published by Globes [online], Israel business news - www.globes-online.com - on October 18, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

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