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FDA approves first antisense oligonucleotide therapy for chronic hepatitis B

Original: The FDA has approved the first antisense oligonucleotide for chronic hepatitis B, giving a defined group of adults a cha

The FDA has approved the first antisense oligonucleotide treatment for chronic hepatitis B, offering a defined group of adults the chance to maintain viral control after stopping therapy. In trials, the benefit reached about one in five participants, and the approval comes with eligibility limits and warnings of serious safety risks. It marks a notable step for a disease long managed with suppressive but rarely curative treatment.

Why now: It is the first approval of a new drug class for chronic hepatitis B, a condition affecting hundreds of millions worldwide.

FDAchronic hepatitis B

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Evidence

• The FDA has approved the first antisense oligonucleotide for chronic hepatitis B, giving a defined group of adults a chance to maintain viral control after stopping therapy. The benefit reached about one in five trial participants, while eligibility limits and serious safety… · news@newtqnia.com · 1

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