Shire has received another FDA approval with the second approval for Vonvendi, a treatment for perioperative bleeding management in adults with VWD.
Savvy pharma investors know to look out for US Food and Drug Administration (FDA) regulatory approvals. Even when a new approval is given for an already approved drug, it should result in higher profits as the drug has more indications.
Such is the case for Shire (NASDAQ:SHPG), which announced on Tuesday (April 17), that it has received expanded approval for Vonvendi, a treatment for perioperative bleeding management in adults with von Willebrand disease (VWD), making it the only recombinant treatment for the disease.
The new approval indication for the treatment is for patient-tailored treatment in a surgical setting to prevent bleeding. The previous 2015 approval was indicated for on-demand treatment and control of bleeding episodes.
VWD is the most common inherited bleeding disorder, affecting roughly 1 percent of the US population. The disease interrupts the body’s ability to clot blood effectively, either from a deficiency or dysfunction from one of the proteins in the blood.
“The expanded approval of VONVENDI represents a new treatment option for the surgical setting that can be tailored to each patient’s individual needs,” Andreas Busch, Shire’s global head of research and development, said in the press release. “It’s an important milestone in support of our vision of personalizing treatment and helping to address unmet needs for people with bleeding disorders.”
This approval expansion was based off results from a Phase 3 clinical trial, which met its primary endpoints. Patients with and without recombinant VWF were given a Vonvendi dose before surgery to achieve intra and postoperative hemostasis.
Shire is a global leader in discovering rare disease treatments for indications in hematology, immunology, genetic diseases, neuroscience and growing the therapies for ophthalmics and oncology.
In a note to investors, Cantor Fitzgerald analyst Louise Chen maintained a “buy” rating Monday (April 16) with a $222 price target on Shire. This rating was based on Shire’s Monday announcement stating it plans to sell its oncology business for $2.4 billion.
Following Tuesday’s FDA approval, Shire’s stock price increased 1.76 percent to close at $155.09. Chen’s most recent price target is the highest price target the company has received in the past two months.
Investors interested in Shire should focus on new product launches in its pipeline, which are expected to be the main financial drivers this year, according to the company’s 2017 financial results.
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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.