- Honda and Nissan to launch merger talks
- Police arrest suspect who set woman on fire in New York subway
- China vows 'cooperation' over ship linked to severed Baltic Sea cables
- Australian tennis star Purcell provisionally suspended for doping
- Luxury Western goods line Russian stores, three years into sanctions
- Wallace and Gromit return with comic warning about AI dystopia
- Philippine military says will acquire US Typhon missile system
- Afghan bread, the humble centrepiece of every meal
- Honda and Nissan expected to begin merger talks
- 'Draconian' Vietnam internet law heightens free speech fears
- Israeli women mobilise against ultra-Orthodox military exemptions
- Asian markets track Wall St rally as US inflation eases rate worries
- Tens of thousands protest in Serbian capital over fatal train station accident
- Trump vows to 'stop transgender lunacy' as a top priority
- 'Who's next?': Misinformation and online threats after US CEO slaying
- Only 12 trucks delivered food, water in North Gaza Governorate since October: Oxfam
- Langers edge Tiger and son Charlie in PNC Championship playoff
- Explosive batsman Jacobs gets New Zealand call-up for Sri Lanka series
- Holders PSG edge through on penalties in French Cup
- Daniels throw five TDs as Commanders down Eagles
- Atalanta fight back to take top spot in Serie A, Roma hit five
- Mancini admits regrets over leaving Italy for Saudi Arabia
- Run machine Ayub shines as Pakistan sweep South Africa
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- 'Incredible' Liverpool must stay focused: Slot
- Maresca 'absolutely happy' as title-chasing Chelsea drop points in Everton draw
- Salah happy wherever career ends after inspiring Liverpool rout
- Three and easy as Dortmund move into Bundesliga top six
- Liverpool hit Spurs for six, Man Utd embarrassed by Bournemouth
- Netanyahu vows to act with 'force, determination' against Yemen's Huthis
- Ali hat-trick helps champions Ahly crush Belouizdad
- Salah stars as rampant Liverpool hit Spurs for six
- Syria's new leader says all weapons to come under 'state control'
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- Lonely this Christmas: Vendee skippers in low-key celebrations on high seas
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- Germany pledges security inquest after Christmas market attack
- Putin vows 'destruction' on Ukraine after Kazan drone attack
- Understated Usyk seeks recognition among boxing legends
- France awaits appointment of new government
US approves first drug for severe form of fatty liver disease
The US Food and Drug Administration (FDA) on Thursday approved the first medication for people with a severe type of non-alcoholic fatty liver disease.
Madrigal Pharmaceuticals' Rezdiffra was shown to improve liver scarring in a clinical trial involving hundreds of people with non-alcoholic steatohepatitis (NASH), the worst form of the condition caused by a buildup of fat in the liver.
"Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage," said the FDA's Nikolay Nikolov.
"Today's approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise."
NASH affects approximately 6-8 million people in the United States, and is often associated with other health problems such as high blood pressure, type 2 diabetes, obesity and high blood fat levels.
Its symptoms include weakness, severe tiredness, yellowing of the skin or eyes, spider-like blood vessels and more. NASH that progresses to cirrhosis -- the latest form of scarring -- will lead to liver failure over time, necessitating a transplant.
Rezdiffra, also known by its molecule name resmetirom, is an oral drug that targets the underlying causes of NASH.
In a trial of 966 people, liver biopsies taken at 12 months showed that a greater proportion of subjects treated with Rezdiffra achieved resolution of their condition or an improvement in liver scarring as compared with those who received the placebo. The results were published in February in the New England Journal of Medicine.
Common side effects included diarrhea and nausea.
"The accelerated approval of Rezdiffra is a culmination of more than 15 years of research from our founder Dr. Becky Taub and a small R&D team that took on one of the biggest challenges in drug development," said Bill Sibold, Madrigal CEO.
The American Liver Foundation's Lorraine Stiehl also hailed the "groundbreaking" treatment.
Madrigal said the drug is set to be available to US patients in April.
L.E.Campos--PC