Gilead says not to pursue U.S. approval for rheumatoid arthritis drug

[December 16, 2020]  (Reuters) -Gilead Sciences Inc said on Tuesday it had decided not to pursue the U.S. Food and Drug Administration's approval for its experimental rheumatoid arthritis treatment, filgotinib, following a meeting with the health regulator.

The FDA in August declined to approve the drug for rheumatoid arthritis after weighing the overall benefit of the 200 mg dose of the treatment against its risk profile.

Gilead said it had concluded that the 200 mg dose of the drug was unlikely to receive a U.S. approval without conducting additional clinical studies.

Last year, Gilead invested $5.1 billion in a major expansion of its partnership with Belgo-Dutch biotech Galapagos NV, banking on the potential of filgotinib and other drugs in development.

The two companies have now amended the pact, with Galapagos assuming sole responsibility in Europe for the drug, where it has been approved for treating moderate to severe forms of rheumatoid arthritis.

Galapagos will also assume all rights for filgotinib in Europe, with Gilead agreeing to pay 160 million euros ($194.43 million) to the company, they said in a joint statement.

Gilead and Galapagos said they no longer believe it was feasible to continue the current clinical trials of filgotinib for psoriatic arthritis, ankylosing spondylitis and non-infectious uveitis.

($1 = 0.8229 euros)

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Anil D'Silva)

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