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Tesaro puts AstraZeneca; XELJANZ® receives; Innovus nabs; Alexion brings

Mar 28, 2017

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Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib

Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27^th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival, Lynparza from AstraZeneca. It’s approved to treat all women with recurrent ovarian, fallopian tube or peritoneal cancer who’ve previously responded to platinum chemo, not just those who test positive for the BRCA genetic mutation. With 2022 sales expectations of $1.9 billion, Zejula is one of the top drug launches of 2017. And with some strong data showing its ability to hold off cancer progression for more than a year in some patients, it could be a quick challenger for market share when it launches, expected in late April.

XELJANZ® receives marketing authorisation in the EU for moderate to severe rheumatoid arthritis

Pfizer Inc. announced that the European Commission (EC) has approved XELJANZ® 5 mg twice daily (BID) oral tablets in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. XELJANZ belongs to a new class of therapies called Janus kinase (JAK) inhibitors. The EC approval is based on a submission package that included results from the Phase 3 Oral Rheumatoid Arthritis triaLs (ORAL) global development program and real world data.

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Alexion brings on former Baxalta chief Hantson to fill vacant CEO spot

Alexion’s CEO search is over. The Connecticut biotech, which bade its skipper farewell late last year, is bringing former Baxalta chief Ludwig Hantson into the fold. Hantson will take the reins from David Brennan, who stepped in as interim CEO after David Hallal made his exit last December. Brennan will remain on Alexion’s board, which expects to appoint him chairman at the company’s mid-May annual meeting, Alexion said.