Latest news with #livercondition
Yahoo
12 hours ago
- Business
- Yahoo
Shares in Novo Nordisk rise after Wegovy gets US nod for liver disease treatment
By Jacob Gronholt-Pedersen COPENHAGEN, DENMARK (Reuters) -Shares in Novo Nordisk rose on Monday, after it got U.S. approval for its weight-loss drug Wegovy to treat a serious liver condition, positive news for the drugmaker that lost more than one-third of its market value in recent weeks. Novo's shares rose as much as 5% at opening and were trading 3.5% higher by 0711 GMT. Three weeks ago, investors wiped $70 billion off its market value, after Novo - which became Europe's most valuable listed company following the launch of Wegovy in 2021 - issued a profit warning and named a company veteran as new CEO. On Friday, the U.S. Food and Drug Administration granted accelerated approval for Wegovy to treat metabolic dysfunction-associated steatohepatitis, or MASH, making it the first GLP-1 class therapy cleared for the progressive liver condition that affects around 5% of adults in the United States. Rival Eli Lilly has published encouraging MASH data in a mid-stage trial with tirzepatide - the active ingredient in its popular diabetes drug Mounjaro and weight-loss treatment Zepbound. "It is expected that this market exclusivity will only last for a transitional phase before Eli Lilly also launches a product on the market," said Nordnet analyst Per Hansen. Novo has also applied this year for approval in Europe and Japan. Its shares have lost more than two-thirds of their value since June last year, amid concerns that the Danish drugmaker is losing ground in the obesity drug race it started to rival Eli Lilly and "compounded" copycat drugs. Sign in to access your portfolio
Yahoo
13 hours ago
- Business
- Yahoo
Shares in Novo Nordisk rise after Wegovy gets US nod for liver disease treatment
By Jacob Gronholt-Pedersen COPENHAGEN, DENMARK (Reuters) -Shares in Novo Nordisk rose on Monday, after it got U.S. approval for its weight-loss drug Wegovy to treat a serious liver condition, positive news for the drugmaker that lost more than one-third of its market value in recent weeks. Novo's shares rose as much as 5% at opening and were trading 3.5% higher by 0711 GMT. Three weeks ago, investors wiped $70 billion off its market value, after Novo - which became Europe's most valuable listed company following the launch of Wegovy in 2021 - issued a profit warning and named a company veteran as new CEO. On Friday, the U.S. Food and Drug Administration granted accelerated approval for Wegovy to treat metabolic dysfunction-associated steatohepatitis, or MASH, making it the first GLP-1 class therapy cleared for the progressive liver condition that affects around 5% of adults in the United States. Rival Eli Lilly has published encouraging MASH data in a mid-stage trial with tirzepatide - the active ingredient in its popular diabetes drug Mounjaro and weight-loss treatment Zepbound. "It is expected that this market exclusivity will only last for a transitional phase before Eli Lilly also launches a product on the market," said Nordnet analyst Per Hansen. Novo has also applied this year for approval in Europe and Japan. Its shares have lost more than two-thirds of their value since June last year, amid concerns that the Danish drugmaker is losing ground in the obesity drug race it started to rival Eli Lilly and "compounded" copycat drugs. Sign in to access your portfolio
Reuters
13 hours ago
- Business
- Reuters
Shares in Novo Nordisk rise after Wegovy gets US nod for liver disease treatment
COPENHAGEN, DENMARK, Aug 18 (Reuters) - Shares in Novo Nordisk ( opens new tab rose on Monday, after it got U.S. approval for its weight-loss drug Wegovy to treat a serious liver condition, positive news for the drugmaker that lost more than one-third of its market value in recent weeks. Novo's shares rose as much as 5% at opening and were trading 3.5% higher by 0711 GMT. Three weeks ago, investors wiped $70 billion off its market value, after Novo - which became Europe's most valuable listed company following the launch of Wegovy in 2021 - issued a profit warning and named a company veteran as new CEO. On Friday, the U.S. Food and Drug Administration granted accelerated approval for Wegovy to treat metabolic dysfunction-associated steatohepatitis, or MASH, making it the first GLP-1 class therapy cleared for the progressive liver condition that affects around 5% of adults in the United States. Rival Eli Lilly (LLY.N), opens new tab has published encouraging MASH data in a mid-stage trial with tirzepatide - the active ingredient in its popular diabetes drug Mounjaro and weight-loss treatment Zepbound. "It is expected that this market exclusivity will only last for a transitional phase before Eli Lilly also launches a product on the market," said Nordnet analyst Per Hansen. Novo has also applied this year for approval in Europe and Japan. Its shares have lost more than two-thirds of their value since June last year, amid concerns that the Danish drugmaker is losing ground in the obesity drug race it started to rival Eli Lilly and "compounded" copycat drugs.
Globe and Mail
3 days ago
- Health
- Globe and Mail
Novo Nordisk's Wegovy gets accelerated U.S. approval for liver disease
Novo Nordisk said on Friday the U.S. Food and Drug Administration had granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition known as metabolic dysfunction-associated steatohepatitis. The decision makes Wegovy the first GLP-1 class therapy cleared for MASH, a progressive liver condition that affects around 5% of adults in the U.S., according to the American Liver Foundation. The approval is for use alongside a reduced-calorie diet and increased physical activity. The FDA's approval was based on part one of a two-part study that showed Wegovy helped more patients with MASH and liver scarring improve the organ's condition, compared to a placebo. At 72 weeks, nearly 37% of patients on Wegovy saw an improvement in liver fibrosis, compared to 22.4% on placebo. Nearly 63% of those on Wegovy had their liver inflammation resolved, versus 34.3% for placebo. No worsening of the disease was seen in these patients. Accelerated approvals allow the agency to move therapies that target serious and life-threatening conditions to the market more quickly. However, such approvals have been criticized because some drugs have later been proven to be ineffective.
Reuters
3 days ago
- Health
- Reuters
Novo Nordisk's Wegovy gets accelerated US approval for liver disease MASH
Aug 15 (Reuters) - Novo Nordisk ( opens new tab said on Friday the U.S. Food and Drug Administration had granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition known as metabolic dysfunction-associated steatohepatitis. The decision makes Wegovy the first GLP-1 class therapy cleared for MASH, a progressive liver condition that affects around 5% of adults in the U.S., according to the American Liver Foundation. The approval is for use alongside a reduced-calorie diet and increased physical activity. The FDA's approval was based on part 1 of a two-part study that showed Wegovy helped more patients with MASH and liver scarring improve the organ's condition, compared to a placebo. At 72 weeks, nearly 37% of patients on Wegovy saw an improvement in liver fibrosis, compared to 22.4% on placebo. Nearly 63% of those on Wegovy had their liver inflammation resolved, versus 34.3% for placebo. No worsening of the disease was seen in these patients. Accelerated approvals allow the agency to move therapies that target serious and life-threatening conditions to the market more quickly. However, such approvals have been criticized because some drugs have later been proven to be ineffective.
