Third Trial For Teva’s Laquinimod Hinges On SPA From FDA
This article was originally published in The Pink Sheet Daily
Teva will initiate a third clinical trial testing the oral multiple sclerosis drug laquinimod after finalizing a special protocol assessment with FDA.
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Teva CEO Jeremy Levin provided additional glimpses of the company’s new strategy on a Q3 earnings call in advance of an investor meeting on Dec. 11, where he and Teva management will reveal their full agenda. Levin again put the emphasis on “focus” and “discipline” over “pure growth,” confirmed the company’s ‘confidence in the MS drug laquinimod, and highlighted several senior management appointments that reflect Teva’s new priorities.
Several new drugs for multiple sclerosis could launch within the next two years, but amid escalating drug costs, payors are taking a harder look at the therapeutic category. New drugs will face increasing reimbursement hurdles, as payors implement the first prior authorization and step therapy protocols and look for ways to implement further cost reductions.
MS drug spending is skyrocketing due to premium-priced new drugs and defensive price hikes across the category, making the therapeutic area a management priority for payers. Insurers are largely relying on aggressive contracting with manufacturers to manage the category, but new launches are unlikely to secure preferred formulary placement without comparative safety and efficacy data.