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AbbVie’s blockbuster-in-waiting for endometriosis gets FDA nod

First new oral treatment in more than 10 years

AbbVie

AbbVie has scored a major new approval from the FDA, getting a green light yesterday for elagolix in endometriosis-related pain – becoming the first new oral drug for the condition in more than 10 years.

The approval of elagolix – which will be sold as Orilissa and carry a list price of $845 per month – is a major step forward for AbbVie as it builds a portfolio of new products that will step into the breach when its $16bn immunology blockbuster Humira is hit by biosimilar competition, starting in Europe later this year and in the US in 2023.

Elagolix will launch early next month in the US and is predicted to grow quickly to the $1bn sales mark, and rise beyond that threshold if additional indications such as uterine fibroids are approved by regulators. The approval is also good news for Neurocrine Biosciences, from which AbbVie in-licensed the drug in 2010 for $575 million.

Orilissa is billed as the first oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for endometriosis pain, and was approved by the FDA under priority review. In trials, it significantly reduced daily menstrual pelvic pain, non-menstrual pelvic pain, and pain associated with sex.

Endometriosis – a condition where tissue lining the womb migrates elsewhere, such as the ovaries and fallopian tubes – has a range of therapies available, including pain medication and hormonal therapies. However, it is notoriously difficult to treat effectively and many drugs have troublesome side effects. In severe cases, surgery may be needed to destroy the misplaced tissue or remove the womb entirely.

It’s also one of the most common gynaecologic disorders, affecting around one in 10 women of reproductive age in the US, and often goes undiagnosed for years.

“Endometriosis is often characterised by chronic pelvic pain that can impact women's daily activities,” said Hugh Taylor of Yale School of Medicine, one of the investigators in Orilissa’s phase III programme.

“Women with endometriosis may undergo multiple medical treatments and surgical procedures seeking pain relief and this approval gives physicians another option for treatment based on a woman's specific type and severity of endometriosis pain.”

AbbVie has a window of opportunity to grow its product before a rival therapy from Takeda and Myovant can reach the market. Their relugolix candidate has positive mid-stage results in endometriosis-related pain, uterine fibroids, and prostate cancer, and is currently in phase III testing with some results due next year.

Article by
Phil Taylor

25th July 2018

From: Regulatory

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