- The Food and Drug Administration has cleared new drugs for severe asthma, bipolar depression and a rare autoimmune disease, granting approvals Friday and Monday to Amgen, Intra-Cellular Therapies and Argenx in a flurry of year-end decisions.
- Amgen and AstraZeneca's asthma treatment, now branded as Tezspire, is a biologic drug that works in a new way to ease the airway inflammation associated with the condition. It's a particularly important medicine for Amgen, which faces growing competition and patent expirations for its current crop of top-sellers.
- Intra-Cellular's approval expands use of the company's drug Caplyta to include bipolar depression and has been particularly anticipated by investors in the New York biotech. Clearance of Argenx's Vyvgart, meanwhile, is the Dutch drugmaker's first FDA approval as well as the first of its type for generalized myasthenia gravis, a chronic condition in which the body's immune cells disrupt communication between nerves and muscles.
Tezspire and Vyvgart are the 47th and 48th new-to-market drugs approved by the Food and Drug Administration's main review office this year, matching 2019's total and nearing the 53 that were cleared last year. (Caplyta was previously approved for schizophrenia.)
One or two more could be forthcoming as well; a decision on Novartis' cholesterol-lowering drug Leqvio, delayed from last December, is due Jan. 1 but may be issued sooner, for example.
Of the three cleared by the FDA Friday and Monday, market expectations are highest for Amgen and AstraZeneca's Tezspire, which is expected to compete with Sanofi and Regeneron's blockbuster inflammatory disease drug Dupixent, among others.
Analysts forecast $1 billion or more in sales by 2025, although Tezspire's approved labeling, which requires administration by a healthcare professional and only covers severe asthma patients, could limit initial uptake, noted SVB Leerink's Geoffrey Porges.
In clinical testing, adding Tezspire to standard asthma drugs reduced the number of "attacks" by more than half. Data from a small clinical trial, however, showed treatment didn't help lower the daily dose of steroids participants needed to control their asthma, a result Amgen's head of research and development called "surprising" at the time.
Tezspire works by blocking a protein known as TSLP, which is thought to prevent the release of other pro-inflammatory proteins that can cause asthma attacks. It's the first drug of its type.
Amgen is not yet disclosing the price of Tezspire, which the company plans to make available in January.
With Vyvgart, Argenx can similarly claim first-in-class status: the drug is the first medicine approved by the FDA that acts against what's known as a neonatal Fc receptor, or FcRn. According to Argenx, inhibiting FcRn reduces circulation of a specific type of antibody that, in people with generalized myasthenia gravis, mistakenly attacks communication between nerves and muscles, causing muscle weakness.
Vyvgart is for a subset of adults with myasthenia gravis that accounts for roughly 85% of all adult patients with the disease. The drug's approval was based on the results of a study published in The Lancet this past July.
For a typical patient, Vyvgart will cost about $225,000 per year, according to a company presentation.
The FDA's approval of Caplyta for bipolar depression, meanwhile, significantly expands the number of patients who are eligible to receive Intra-Cellular's drug, which has been available for use in treating schizophrenia since December 2019.
The drug was cleared for use by itself and as adjunctive therapy together with lithium or valproate for depressive episodes associated with either bipolar I or bipolar II disorder, which Intra-Cellular estimates affect about 11 million adults in the U.S.
Shares in Intra-Cellular rose by nearly 25% in Monday morning trading, while Amgen fell by nearly 2% and Argenx rose by 9%.