FDA Approves AbbVie's Parkinson's Treatment, Medicare Coverage Expected Next Year

Benzinga · 10/17 15:31

On Thursday, the FDA approved AbbVie Inc’s (NYSE:ABBV) Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for motor fluctuations in adults with advanced Parkinson’s disease (PD).

The approval was supported by the pivotal 12-week Phase 3 study evaluating the efficacy of continuous subcutaneous infusion of Vyalev in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR), along with a 52-week, open-label study which evaluated the long-term safety and efficacy of Vyalev.

Also Read: AbbVie Says Pivotal Trial For Parkinson’s Candidate Meets Its Primary Goal In Patients With Early Disease.

Findings from the pivotal study showed patients receiving Vyalev demonstrated a superior improvement in motor fluctuations, with increased “on” time without troublesome dyskinesia and decreased “off” time, compared with oral CD/LD IR.

“On” time refers to the periods of time when patients are experiencing optimal motor symptom control, while “off” time is when symptoms return.

Vyalev allows for personalized dosing based on individual needs, morning, day, and night.

PD is a progressive and chronic movement disorder resulting in tremors, muscle rigidity, slowness of movement, and difficulty with balance resulting from the loss of dopamine-producing brain cells.

Coverage for Medicare patients is expected in the second half of 2025.

AbbVie Stock Prediction For 2024

Equity research analysts on and off Wall Street typically use earnings growth and fundamental research as a form of valuation and forecasting. But many in trading turn to technical analysis as a way to form predictive models for share price trajectory.

Some investors look to trends to help forecast where they believe a stock could trade at a certain point in the future. Looking at AbbVie, an investor could make an assessment about a stock's long term prospects using a moving average and trend line. If they believe a stock will remain above the moving average, which many believe is a bullish signal, they can extrapolate that trend into the future using a trend line. For AbbVie, the 200-day moving average sits at $176.24, according to Benzinga Pro, which is below the current price of $189.49. For more on charts and trend lines, see a description here.

Traders believe that when a stock is above its moving average, it is a generally bullish signal, and when it crosses below, it is a more negative signal. Investors could use trend lines to make an educated guess about where a stock could trade at a later date if conditions remain stable.

Price Action: ABBV stock is down 0.28% at $189.93 at last check Thursday.

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