Bethesda, Maryland, Nov. 17 (Bloomberg) -- Novartis AG and
QLT PhotoTherapeutics Inc.'s experimental Visudyne eye drug
should be approved for use in treating the leading cause of age-
related blindness in older Americans, members of an expert
government panel said.
The advisory panel for the U.S. Food and Drug Administration
weighed a new drug application for Visudyne, which was discovered
by QLT, a money-losing company specializing in light-activated
therapies. Novartis, the world's second-biggest drugmaker, will
market the treatment if it is approved.
The panel didn't vote on safety or effectiveness or make a
formal recommendation, and the FDA did not request such action.
Still, panel members said during deliberations that they believed
the drug offered an important weapon against the disease and
should be approved.
''This is terrible disease that steals vision away from
people,'' said George Cioffi, a panel member and eye doctor at
the Devers Eye Institute in Portland, Oregon. ''Even the modest
effect of a six-month window (of sight), added on to an 81-year-
old's life -- I think that is significant. I think it is a
reasonable drug and we should seriously consider approving it.''
The FDA generally follows the advice of its expert advisors.
Panel members said the drug had a modest effect on a group
of patients and asked to see two-year follow-up data to better
gauge the durability of Visudyne's effects, before the drug gets
FDA clearance.
QLT officials said the company had gathered nearly all of
that data and could submit it to the agency soon. Shares of QLT
were halted during the hearing.
Novartis and QLT are seeking clearance to treat patients
with a condition known as ''wet'' age-related macular
degeneration, which strikes about 500,000 people worldwide each
year.
Novartis officials have said the drug has the potential to be
the biggest-selling ophthalmic treatment ever and analysts said
before the panel hearing that the drug could have sales of $690
million in 2003.
Basel, Switzerland-based Novartis said that it will split
the profit from Visudyne 50-50 with Vancouver, British Columbia-
based QLT. |
