Biogen to start new Spinraza trial to preserve market share
pharmafile | September 20, 2019 | News story | Medical Communications, Research and Development |
Biogen is planning a new trial of $1.7billion-a-year Spinraza to investigate much higher doses in spinal muscular atrophy (SMA) and thwart off competition from new player Zolgensma from Novartis.
The new phase 2/3 trial entitled DEVOTE will enrol 126 patients of all ages, including adults and will compare a maintenance dose of 28mg to the currently approved 12mg.
The FDA-approved 12mg dose was based on data in infants with the possibility of higher doses working better in teenagers and adults not having yet been investigated.
One analyst described Biogen’s move as “Spinraza on the offensive” noting that “what we never learned was whether the effect could have been greater at higher doses” – additionally Novartis rolled out its Zolgensma treatment in March and already has some payers on board in spite of a controversial list price of $2.125 million.
Just last week, Cigna announced a new programme that will fully cover Zolgensma, with no out-of-pocket cost for patients.
CEO Michel Vounatsos downplayed the Zolgensma competition stating it was “premature to make assumptions” about the uptake of the gene therapy.
Biogen is now on an aggressive plan with Spinraza as challenges are coming; for instance during the second quarter, sales fell by 6% to $488 million, falling short of many analysts’ estimates.
As of June 2019, more than 8,400 individuals have been treated with Spinraza for up to nearly six years.
Alfred Sandrock, Executive Vice President and Chief Medical Officer at Biogen, said: “Spinraza has fundamentally changed the natural history of SMA.
“Antisense oligonucleotides directly intervene at the origin of the disease providing a transformative therapeutic option. Spinraza’s highly targeted approach and well-characterised safety profile allows us to continue exploring ways to potentially address the remaining medical needs in the SMA community.”
Nik Kiran
