Novartis hopes to distribute Zolgensma, its pricey spinal muscular atrophy drug, via lottery; Merck receives FDA approval for its Ebola vaccine, Ervebo; a new law in California hopes to resurrect compassionate use cannabis programs.
At a price tag of $2.1 million for 1 dose, Novartis’ Zolgensma (onasemnogene abeparvovec), which the FDA approved in May, making it only the second medication approved to treat spinal muscular atrophy (SMA), is the world’s costliest drug. Now, the pharma giant’s AveXis division has created a controversial lottery for distributing 100 doses of the drug in 2020 in countries where it is not yet approved, according to Reuters. Every 2 weeks until their eligibility expires, babies will be entered into the drawing. TreatSMA, a British advocacy group, has voiced its hesitancy about the lottery, but is seeking additional input before releasing its official position. Biogen’s Spinraza (nusinersen) was the first drug approved to treat SMA, with a cost of $750,000 for the first dose and $375,000 for subsequent doses.
Ervebo, Merck’s vaccine to treat Ebola, was approved by the FDA yesterday, according to Stat News, following a similar decision by the European Commission on November 11. The drug will be used as protection against Zaire ebolaviruses, which is the species of virus most frequently cited as the cause of an Ebola outbreak. It will likely be stockpiled by several countries to protect against potential bioterrism attacks and for emergency use in cases of an outbreak. In the current Ebola outbreak in the Democratic Republic of the Congo, 3350 have been infected with Ebola and 2220 have died. Merck has qualified for a tropical disease priority review voucher because of the vaccine, and it can use that to fast-track FDA review of a future drug.
In 1996, California passed the Compassionate Use Act, allowing medicinal use of marijuana. However, Proposition 64 in 2016 legalized recreational marijuana use in the state, and the tax rate on cannabis—more than 38% in some cases—made the drug unaffordable for those who needed it most. SB-34 hopes to reverse that and prevent patients from turning to the black market by lessening the financial liability. Signed by Governor Gavin Newsom in October, the new law would remove the cultivation, retail, and excise taxes imposed on cannabis donated for compassionate use, according to Kaiser Health News, and allow patients with cancer, AIDS, and glaucoma to once again afford the usually expensive remedy they use to treat their disease symptoms.