Hyqvia fda approval?

See the DrugPatentWatch profile for Hyqvia

When was Hyqvia FDA-approved, and under what circumstances was it approved?

Hyqvia is an IgPro20 formulation of recombinant human IgG1λ and IgG1κ monoclonal antibodies, used for the treatment of adults and children (including those 2 years and older) with primary immunodeficiency (PID) who are deficient in IgG.

Hyqivia received FDA approval on April 1, 2014 [1]. The drug consists of a single vial of IgG1 and a separate device used to reconstitute it, which is intended to be co-administered to the patient. The FDA approved this drug under its accelerated approval pathway.

Who developed Hyqvia, and what is the current patent status?

Hyqvia is a product of Viropharma Inc. (now part of Shire), which has partnered with CSL Behring to distribute the product [2]. According to DrugPatentWatch.com, the U.S. patent protecting the IgPro20 formulation expired in February 2028 [3]. However, there could be potential generic equivalents to Hyqivua in development.

What clinical trials supported the FDA approval of Hyqvia?

The efficacy and safety of Hyqvia were evaluated in clinical trials assessing the drug in patients with PID. The primary endpoint was the increase in trough IgG concentration (IgG trough level). Results from these trials showed a significant increase in IgG levels in patients treated with Hyqvia. The most common adverse reactions included headache, fatigue, nausea, and skin reactions [1].

How long does Hyqvia have FDA-exclusivity?

The FDA approved Hyqvia under its accelerated approval pathway, which requires the drug to have 'substantial evidence of effectiveness' based on a randomized, controlled clinical trial. Under the law, if the sponsor cannot obtain a complete response to the Biologics License Application within four years, the FDA is required to take appropriate regulatory action to approve a competing product. The four-year exclusivity period is set to expire in April 2018.

Sources:

[1] FDA Approval Letter for Hyqvia on the FDA website: https://www.fda.gov/media/104555/download

[2] Viropharma Announces Collaboration with CSL Behring to Develop and Market HYQVIA in the United States on the Viropharma website: https://web.archive.org/web/20150104155555/http://www.viropharma.com/news/pressreleases/pressreleases_detail.aspx?id=1376

[3] Patent Expiration Dates and Patent History on DrugPatentWatch: https://www.drugpatentwatch.com/patent/US-8535715-B1/