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Tesaro Hid Anaphylaxis with Injectable Varubi, Says Securities Class Action

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Injectable Varubi

Tesaro, Inc. had an approved, oral drug which it wanted to offer in an intravenous form. But it seems that the process was not that simple, and the complaint for this class action claims that the company hid bad news from the public.

The class for this action is all persons who acquired Tesaro securities between March 14, 2016 and January 12, 2018 and who were damaged at the corrective disclosures.

Tesaro is a biopharmaceutical company that develops cancer therapeutics and products for supportive care for oncology in the US. One of its drugs is Varubi (rolapitant), which helps prevent the nausea and vomiting that chemotherapy sometimes causes. The oral version was approved by the Food and Drug Administration (FDA) in 2015.

On the first day of the class period, March 14, 2016, Tesaro announced it was submitting a New Drug Application (NDA) to the FDA for an intravenous (IV) form of Varubi. The press release said the application was “supported by data from a clinical program that enrolled more than 400 subjects and included a bioequivalence study and several other supportive non-clinical studies.” It claimed to anticipate a twelve-month review period.

In subsequent press releases and SEC filings, Tesaro made other hopeful statements on the drug and its developments:

  • It submitted a Marketing Authorisation Application (MMA) for the oral version to the European Medicines Agency (EMA) in March 2016.
  • The EMA had accepted it for review.
  • The FDA application for the IV version had a target Prescription Drug User Fee Act (PDUFA) date of January 11, 2017.
  • The FDA requested more information on “the in vitro release method” for the IV version.
  • The company hoped to launch the oral version in Europe and IV version in the US in the second half of 2017.
  • The company resubmitted its NDA to the FDA in April 2017.
  • The oral version was approved for sale in Europe.
  • The FDA approved the IV form, which the company announced on October 25, 2017.

However, on January 12, 2018, Tesaro issued a press release on the IV version of the drug. The complaint quotes it as saying, “Anaphylaxis, anaphylactic shock, and serious hypersensitivity reactions have been reported in the postmarket setting, some requiring hospitalization.” It also said that Tesaro had issued a “Dear Healthcare Professional” letter to warn prescribers of the danger.

The complaint alleges that the company’s failure to mention the problems with the IV version of the drug violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.

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