NORTH CHICAGO, Ill. - AbbVie Inc . (NYSE:ABBV) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning its New Drug Application (NDA) for ABBV-951, intended for adults with advanced Parkinson's disease. The FDA's letter, announced today, cites observations from an inspection at a third-party manufacturing facility involved in the NDA, although the facility is not directly associated with ABBV-951 or any other AbbVie medication.
The CRL, while highlighting manufacturing concerns, does not raise any issues regarding the safety, efficacy, or labeling of ABBV-951, including its device component. Additionally, the FDA has not requested further clinical trials for efficacy or safety, nor additional device-related testing.
ABBV-951, a combination of carbidopa and levodopa prodrugs delivered through a 24-hour continuous subcutaneous infusion, has been designed to treat motor fluctuations in patients suffering from advanced Parkinson's disease. The treatment has already been approved in 34 countries, with over 2,100 patients worldwide commencing therapy.
Despite the setback in the U.S., AbbVie has expressed its commitment to work with the FDA to resolve the manufacturing issues and bring ABBV-951 to the U.S. market promptly. "There remains a tremendous unmet need for treatment options for patients living with advanced Parkinson's disease in the United States," said Roopal Thakkar, M.D., senior vice president and chief medical officer at AbbVie.
The company has a broad focus on developing innovative medicines across several key therapeutic areas, including immunology, oncology, neuroscience, eye care, and Allergan (NYSE:AGN) Aesthetics.
This article is based on a press release statement from AbbVie.
In other recent news, AbbVie, the pharmaceutical giant, has seen a significant shift in its market dynamics. Piper Sandler recently raised its price target for AbbVie shares from $185.00 to $190.00, maintaining an Overweight rating. This revision was based on new survey data and an anticipated EU approval of a crucial drug. The firm's analysis also anticipates an increase in revenue for AbbVie in the coming years.
In addition to these developments, AbbVie has finalized the acquisition of Landos Biopharma, integrating the promising investigational drug, NX-13, into its portfolio. The company also announced a partnership with FutureGen Biopharmaceutical to develop FG-M701, a novel TL1A antibody aimed at treating inflammatory bowel disease.
On the financial front, Deutsche Bank has reiterated its Hold rating on AbbVie shares, while Cantor Fitzgerald has initiated coverage on AbbVie, assigning an Overweight rating and establishing a 12-month price target of $200.
Amidst these advancements, AbbVie is implicated in the opioid crisis settlements, which exceed $46 billion. Lastly, despite the competition from biosimilars, AbbVie's flagship arthritis medication, Humira, has maintained over 80% of its patient base.
InvestingPro Insights
As AbbVie Inc. (NYSE:ABBV) navigates the regulatory landscape with its New Drug Application for ABBV-951, investors and stakeholders are closely monitoring the company's financial health and market performance. Notably, AbbVie boasts a robust market capitalization of $305.04 billion, reflecting investor confidence and the company's significant presence in the pharmaceutical industry.
According to InvestingPro data, AbbVie's Price/Earnings (P/E) ratio stands at 23.21 for the last twelve months as of Q1 2024, suggesting that the stock may be trading at a premium compared to earnings. This is further supported by a high Price/Book ratio of 38.1, indicating that investors are willing to pay a higher price for each dollar of book value.
One of the key InvestingPro Tips for AbbVie is its consistent track record of raising dividends for 11 consecutive years, which could be a signal of the company's commitment to returning value to shareholders. Additionally, analysts predict that the company will be profitable this year, backed by a strong free cash flow yield, which is an important metric for investors looking for companies with solid financial foundations and the ability to sustain dividends and investments in growth.
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