Horizon Therapeutics plc (HZNP - Free Report) announced that the FDA has granted approval to Tepezza (teprotumumab-trbw) as a treatment for patients with thyroid eye disease (“TED”). Previously, the FDA had set an action date of Mar 8, 2020.
With this approval, Tepezza becomes the first FDA-approved medicine for the treatment of active TED, which has a significant unmet need. An FDA advisory committee had recommended the approval of the drug in December last year.
The company will conduct a post-marketing study to evaluate safety of Tepezza in a larger patient population, as part of the discussion with the advisory committee.
Shares of Horizon Therapeutics were up 2% in pre-market trading on Jan 22, following the early approval. The company’s shares have surged 74.9% in the past year against the industry’s decline of 1.4%.
The company had filed a biologics license application for Tepezza in July 2019 based on data from the phase III confirmatory study, OPTIC, and positive phase II results. TED is a rare, autoimmune disease in which the insulin-like growth factor receptor (IGF-1R) is overexpressed on eye tissues.
The OPTIC study found that significantly more patients treated with teprotumumab had a meaningful improvement in proptosis, or bulging of the eye, as compared to placebo (82.9% of teprotumumab patients compared to 9.5% of placebo patients). All secondary endpoints were also met. The study was initiated after the phase II study demonstrated clinically meaningful and highly statistically significant results in reducing proptosis and in the symptoms of TED, as measured by overall treatment response.
While developing novel therapies for rare disease, Horizon Therapeutics is also focused on label expansion of key drugs like Krystexxa, Actimmune, Procysbi and Ravicti.
In October 2019, the company initiated the PROTECT study, evaluating the effect of Krystexxa on serum uric acid levels in kidney transplant patients with uncontrolled gout. Actimmune is currently being developed in combination with Roche’s (RHHBY - Free Report) Herceptin, or Bristol-Myers’ (BMY - Free Report) Opdivo and Merck’s (MRK - Free Report) Keytruda, targeting several cancer indications.
Horizon Therapeutics reports through the Orphan and Rheumatology segment, and the Inflammation segment. The company’s net sales in the first nine months of 2019 were $936.5 million, up almost 10% year over year. Tepezza’s approval is likely to boost its sales in 2020.
Horizon Therapeutics currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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