In a first for deuterated drugs, FDA (finally) OKs Teva’s would-be Huntington’s blockbuster Austedo

Ten months after the FDA put Teva’s would-be blockbuster deutetrabenazine on hold after raising some suspicions regarding certain metabolites found in patients, the FDA has given the drug an OK for Huntington’s chorea.

Michael Hayden, Teva

This is a first FDA approval in the world of deuterated drugs, which tweaks therapies so that they break down more slowly in patients. That way you can use a lower dose to greater effect. In this case the drug is a small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, which is designed to regulate the levels of dopamine in the brain.

The drug will be sold as Austedo. Teva shares $TEVA surged 2.2% Monday evening.

A star-crossed Teva paid $3.5 billion to acquire Auspex for this drug two years ago, supposedly setting up a slap shot at the first regulatory OK. That approval was very slow coming, but the payoff has finally arrived.

The big drawback in the approval is that it came with a black box warning on depression and suicidality. ButTeva also wasted no time in tackling the market with an aggressive price point. Jason Gerberry at Leerink noted:

While physicians will titrate Austedo, the average dosage is expected to be 24mg per day which TEVA priced at $60,000 for a year of therapy and is below the list price of (Valeant’s) brand Xenazine ($152K) and generic tetrabenazine ($96K). We view tonight’s update as a positive, eliminating any lingering concerns around deeper issues with the CRL (complete response letter) that delayed Austedo approval. We currently forecast $850m in 2023E Austedo sales.

Several new drugs have now been released with discount pricing, underscoring a new, harsher environment on high drug prices.

Teva has also been pushing this drug along for tardive dyskinesia, though its mixed batch of late-stage data spurred some analysts to sing the praises of a competing drug from Neurocrine. EvaluatePharma has tagged this drug as a potential blockbuster, with a shot at earning slightly more than a billion dollars a year — though that kind of cash won’t come easily.

Still, the FDA approval marks a big win for Teva, which has been under the gun for years now. Currently being restructured, the CEO departed recently as Teva’s generic business is assaulted by lower prices and its branded division endured a lengthy drought in R&D.

The approval also marks a big plus for Concert Pharmaceuticals $CNCE, which has been laboring at deuterating drugs with the heavy hydrogen for years now.

Huntington’s, a lethal neurodegenerative disease, is characterized by harsh, repetitive twisting and writhing associated with chorea.

“Chorea is a major symptom for many living with Huntington disease. It impacts patients’ functionality and activities of daily living, and there have been limited treatment options for these patients,” said Michael Hayden, the CSO at Teva. “Based on the results demonstrated in the clinical development program which supported the approval of AUSTEDO and our ongoing commitment to patients, we feel uniquely positioned to bring this treatment option forward.”

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