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New migraine drug approved 18.12.23 AM

Posted 18 December 2023 AM

The TGA has finally approved AbbVie's oral migraine prevention drug Aquipta after it was considered by the reimbursement committee in July.

While the PBAC knocked back the application, the TGA has approved its use for prophylaxis in adults who have at least four migraine days per month.

The drug, sold under the brand name Qulipta in the US, is sponsored by AbbVie's subsidiary Allergan in Australia.

The regulator also approved Boucher & Muir's Testosterone ADVZ 1000, marking the first generic competitor for Bayer's PBS-listed Reandron 1000, a testosterone replacement in primary and secondary male hypogonadism.

In the year to November, Reandron 1000 earned Bayer $9.1 million in pre-rebate PBS benefits.

Meanwhile, Accord Healthcare has registered the first topical medicine containing tacrolimus under two brand names - Azematop and Tacrolimus Intas - for atopic dermatitis.

Existing oral drugs containing tacrolimus are indicated as an adjunct treatment to liver, kidney, lung or heart allograft transplantation in adults and children.

Tiffany Walker

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