Chinese regulators approve GSK’s Benlysta for lupus nephritis

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that China’s National Medical Products Administration (NMPA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN), a type of kidney disease affecting more than half of those with systemic lupus erythematosus (SLE).

Benlysta is the only biologic approved to treat SLE and lupus nephritis in China.

The recent indication is constrained to patients receiving standard of care for LN.

The indication for SLE, the most common form of lupus, covers adults and children at least five years old.

FDA approved Benlysta as a lupus treatment in 2011. Approval extended to children at least five years old in 2019. In December 2020, FDA approved an indication of the drug for adults with lupus nephritis.

NMPA approved the new indication after reviewing data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) Phase stu…

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FDA approves AstraZeneca’s Saphnelo as a new lupus treatment

AstraZeneca (LON:AZN) has won FDA approval for Saphnelo (anifrolumab-fnia) to treat moderate to severe systemic lupus erythematosus (SLE) in adults.

The drug is the first treatment for SLE to win FDA approval in more than one decade.

Saphnelo targets the type I interferon (IFN) pathway, which plays a role in the pathophysiology of lupus. Researchers have linked elevated levels of type I IFN signaling with increased disease activity and severity.

“We have known since the 1970s that interferons were involved with lupus,” said Dr. George Tsokos, a member of the Lupus Foundation of America Medical-Scientific Advisory Council, in a statement. “With the approval of Saphnelo, we now have one more drug that allows us to translate valuable research knowledge into clinical practice with multiple benefits for our patients with lupus.”

In approving the drug, FDA considered data from two TULIP Phase 3 trials and the MUSE Phase 2 trial.

Across those stud…

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