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The second of the highly anticipated candidates for the AbbVie blockbuster 2019 has arrived.
On Friday, the FDA approved Rinvoq, a rheumatoid arthritis drug for the best-selling Humira, while imitators bite into sales. The new product is expected to be available in the United States by the end of August, AbbVie said.
AbbVie did not return a request for pricing information in a timely manner, but the company said in a statement: "continue to work closely with key stakeholders to support patient access to Rinvoq, including providing a patient support program and a co-payment card that can reduce direct costs to $ 5 per month for eligible, commercially insured patients. "
Regulators based their decision on a Phase 3 program called Select, with 4,400 patients in five studies. Along the way, Rinvoq, who belongs to the emerging class of JAK inhibitors, has shown that he could surpass his anti-TNF predecessor in terms of effectiveness.
"This is a very important data point for us in the program because we are the first JAK inhibitor to have one-on-one ability to show a predefined superiority criterion with multiple criteria," said Aileen Pangan. , medical director of clinical development at AbbVie, said in an interview before approval.
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The JAK group did not hit the scene without its problems, however. Blood clots have been reported in the class. In response, the FDA recently restricted Pfizer's use of Xeljanz in the treatment of ulcerative colitis and added a "Black Box" warning to the drug's label. For Rinvoq, a pharma-reported haemorrhagic stroke and pulmonary embolism had "pre-existing cardiovascular risk factors" that appeared in phase 3.
Pangan, however, stated that the investigators had observed clots in all groups of patients participating in the Rinvoq trial and that venous thromboembolism rates were "comparable" between the 15 mg doses of Rinvoq and Humira.
"It is observed, but it is a known risk in patients with rheumatoid arthritis," she said.
AbbVie hopes that the Med will be able to overcome this hurdle and reach the $ 2.2 billion a year expected by analysts by 2023. And while this figure will remain well below that of Humira, the giant generated $ 4.8 billion globally in the second quarter, but AbbVie has much to do to replace lost sales at the expense of competition.
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Rinvoq will not take care of this task alone either. In April, the Illinois pharmaceutical industry endorsed Skyrizi, a psoriasis fighter who is already making waves in this overcrowded area. After being launched in May, the drug generated sales of $ 48 million in the second quarter, far exceeding Wall Street's estimates for some of the best "launch numbers in my memory," said analyst Steve Scala. from Cowen & Co., at the AbbVie Gains Conference. call.
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