Novartis Published Incorrect Beovu Safety Data, Employee Lawsuit Claims

Novartis has been accused of failing to disclose accurate Beovu safety data in a whistleblower lawsuit from a former employee. Beovu side effects have been the subject of a class action lawsuit investigation.

In the days leading up to the approval of Beovu, a macular degeneration injectable treatment, one Novartis employee was reportedly urging her employer to correct inaccurate Beovu safety data. Instead of correcting their misleading error, Novartis allegedly fired this employee for speaking up.

In her whistleblower lawsuit, the former Novartis worldwide brand medical director contends that Beovu safety data inaccurately indicated that the stroke and heart attack risk for a competitor product was double the risks seen with Beovu. This information was reportedly inaccurate, with the employee describing the risks from the two drugs to be comparable.

In addition, Novartis’ published Beovu safety data allegedly included a “material omission” which misrepresented ocular inflammation rates. This data reportedly said that the rates of ocular inflammation seen in their product exceeding those seen in a competitor product.

The plaintiff says that she “reasonably believed that Novartis’ failure to disclose material information violated consumer safety laws, was fraudulent or criminal, and/or violated public policy concerning public health, safety, and welfare.”

“Novartis retaliated against [her] by conducting a sham investigation and ultimately terminating her employment,” the Beovu whistleblower lawsuit contends.

Novartis’ investigation reportedly centered around a series of events connected to the plaintiff’s visa requirements, as she had previously worked in Canada. These allegations were allegedly used to silence the plaintiff and fire her.

In a statement to STAT, Novartis said that any inaccurate Beovu safety data was corrected between February and September 2018 and disclosed to clinical investigators and steering committees. Since these corrections, Beovu safety data presentations included accurate information. The company says that, even after making the corrections, the overall findings of their Hawk and Harrier clinical trials were unchanged.

The company maintains that the whistleblower lawsuit from their former employee “is without merit” and will be vigorously defended by their lawyers.

Beovu: Overview & Side Effects

Beovu is an injectable drug which was approved by the FDA for the treatment of wet age-related macular degeneration (wet AMD). Unlike dry AMD, wet AMD is caused by an overgrowth of blood vessels under the macula – leading to vision loss. Beovu treats this condition by suppressing the human vascular endothelial growth factor (VEGF) in the eyes – thereby controlling abnormal blood vessel growth.

According to Novartis’ Beovu website, the drug is associated with several side effects such as:

• Blurred vision.
• Cataracts.
• Conjunctival hemorrhage (broken blood vessels in the eye’s surface).
• Vitreous floaters.
• Eye pain.
• Intraocular inflammation.
• Increased intraocular pressure.
• Retinal hemorrhage.
• Vitreous detachment.
• Conjunctivitis.
• And more.

Although the manufacturer notes that the instances of adverse side effects occur in less than 10% of patients, these side effects have sparked concern amongst patients and healthcare providers. Conditions like retinal vasculitis, retinal vein occlusion, retinal detachment and other symptoms have been noted as a particular concern due to their potential for vision loss and total blindness.

Beovu Safety Data Sparks Updated Label Information

In June, Beovu safety data culminated in a new label update for the medication due to concerns of severe eye problems such as retinal vasculitis and retinal vascular occlusion. With the new label, these conditions are warned about in the “Warnings and Precautions” section of the label.

“This label update provides clinicians with important information to guide treatment decisions,” Marcia Kayath, Novartis’ Global Head of Medical Affairs and Chief Medical Officer said in a press release following the label change.

“We believe Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile.”

Despite this positive outlook, the risk for serious eye issues prompted NOvartis to cancel three Beovu trials. The trials aimed to explore more frequent dosing for Beovu patients.