Left Menu
Development News Edition

UPDATE 1-Novartis says knew of Zolgensma data problems before U.S. approval

Reuters | Bern | Updated: 07-08-2019 19:47 IST | Created: 07-08-2019 19:43 IST
UPDATE 1-Novartis says knew of Zolgensma data problems before U.S. approval
Image Credit: Flickr

Swiss Drugmaker Novartis AG on Wednesday said it knew about discrepancies in data it submitted to regulators as it sought approval of its more than $2 million gene therapy Zolgensma, but delayed notifying authorities until it completed an internal investigation. Novartis faces possible civil or criminal penalties from the U.S. Food and Drug Administration, which said on Tuesday that some data was manipulated from early testing of Zolgensma, the world's most expensive treatment. The FDA said the company was aware of the problems for as much as two months before the drug's U.S. approval.

"We made the decision to progress our quality investigation prior to informing FDA and other regulatory authorities so that we could provide the best information and technical analysis, which we did promptly on completion on June 28," Novartis Chief Executive Vasant Narasimhan said on a conference call with analysts. Narasimhan said the decision to delay notifying regulators was not tied to the timing of the drug's approval process.

Zolgensma was approved in late May as a one-time treatment for spinal muscular atrophy (SMA), the leading genetic cause of death in infants. The disease often leads to paralysis, breathing difficulty and death within months for babies born with the disease. The FDA said on Tuesday it did not believe the manipulation affects the safety or later human testing of the drug, and it believes the treatment should remain on the market. The manipulated data was used to illustrate comparability between an early version of Zolgensma and the current version of the treatment, which is manufactured using a different process.

Narasimhan said Novartis received the allegations of data manipulation in mid-March, more than two months before the gene therapy's U.S. approval. The company finished a preliminary investigation into the allegations in early May, confirming data discrepancies and raising data integrity concerns, the CEO said.

Novartis followed that up with a "full technical quality investigation" of the data. On June 28, Narasimhan said the company communicated its findings to the FDA. It notified regulators in Europe and Japan shortly afterward and does not expect the issues to affect the timing of Zolgensma's development there.

Novartis said it was in the process of "exiting" the scientists responsible for the manipulation and does not believe the issue extends beyond those scientists. Zolgensma is no longer on track for accelerated approval in Europe, but the company said it still expects approval there in the fourth quarter.

Shares of the Swiss drugmaker were down 3.4% to 85.64 Swiss francs on Wednesday.


TRENDING

OPINION / BLOG / INTERVIEW

South Africa's COVID-19 response: Surprising outcomes or just poor data management?

South Africa has been committed to improving its health information system and shows that a robust digital has considerable scope to improve healthcare for the entire population. But the COVID-19 pandemic has highlighted that significant ga...

Post-COVID-19 Nigeria needs a robust Health Management Information System to handle high disease burden

Nigeria is among a few countries that conceptualised a health management information system HMIS in the early 90s but implementation has been a challenge till date. Besides COVID-19, the country has a huge burden of communicable and non-com...

Morocco COVID-19 response: A fragile health system and the deteriorating situation

Learning from its European neighbors, Morocco imposed drastic measures from the initial stages of the COVID-19 outbreak to try to contain its spread. The strategy worked for a few months but the cases have surged after mid-June. In this sit...

COVID-19: Argentina’s health system inefficiencies exaggerate flaws of health information system

You can recover from a drop in the GDP, but you cant recover from death, was the straightforward mindset of Argentinas President Alberto Fernndez and defined the countrys response to COVID-19. The South American nation imposed a strict...

Videos

Latest News

Child poverty likely to increase in EU amid virus pandemic

The European Unions external auditor said Tuesday that child poverty has reached an unacceptable level across the worlds largest economy, a situation likely to worsen during the coronavirus pandemic. According to EU data, almost 23 million ...

Sebi notifies easier rights issue norms

Markets regulator Sebi has notified new rights issue rules to rationalise the eligibility criteria and disclosure requirements to make fund raising easier, faster and cost-effective. The regulator has amended the Sebi Issue of Capital and D...

India's COVID-19 recoveries highest in the world: Health Ministry

Indias COVID-19 recoveries have crossed 51 lakh, which is highest in the world, and the last 10 lakh recoveries came about in 11 days, Health Ministry said on Tuesday. The number of recovered COVID-19 patients in the country has crossed 51 ...

HIGHLIGHTS-Tennis-French Open day three

Highlights of the third day at the French Open, the final Grand Slam tournament of the year, on Tuesday all times GMT 1120 PLISKOVA BATTLES PAST SHERIF, OSTAPENKO THROUGHSecond seed Karolina Pliskova of the Czech Republic overcame a sluggis...

Give Feedback