Spinraza’s growth in the United States

Spinraza, Biogen’s (BIIB) SMA (spinal muscular atrophy) therapy, was approved by the FDA (U.S. Food and Drug Administration) on December 23, 2016. Like Alexion Pharmaceuticals’ (ALXN) Soliris, Vertex Pharmaceuticals’ (VRTX) Orkambi, and United Therapeutics’ (UTHR) Unituxin, Spinraza has also been granted orphan drug designation by the FDA.

Since Spinraza is the first approved drug for SMA, it witnessed robust demand trends in 1Q17. Biogen is also involved in further strengthening the infrastructure for the administration of the drug as well as improving patient access for the therapy.

In 88 sites across 36 US states, Spinraza is already being administered to patients. To date, most of these sites have delivered the drug to only one or two patients, but there are a few sites where up to ten patients have been dosed with the drug. Approximately 203 new sites have submitted start forms to get access to Spinraza.

If Biogen manages to boost the underlying demand for Spinraza, it may have a favorable impact on Biogen stock as well as the iShares Core S&P 500 (IVV). Biogen makes up about 0.31% of IVV’s total portfolio holdings.

Biogen’s Spinraza Witnessed Robust Patient Demand in 1Q17

International market growth

Through Biogen’s expanded access program, Spinraza will be administered to 353 type 1 SMA patients in international markets. Of these, 306 patients are from Europe. The expanded access program helps patients access drugs not yet approved and launched in their countries.

On April 21, 2017, Spinraza received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. That increases the chances for regulatory approval in most European markets in the next few months. Biogen also expects to secure regulatory approval for Spinraza in Japan, Canada, and ten other countries in 2017.

In the next part of this series, we’ll look at the access strategy for Spinraza.

Latest articles

On June 18, semiconductor stocks filled the list of the top gainers in the S&P 500 Index after US President Donald Trump confirmed in a phone conversation with Chinese President Xi Jinping that the two would meet at the G20 Summit in Japan on June 28–29.

18 Jun

Chipotle or Shake Shack: Which Is a Better Pick?

WRITTEN BY Rajiv Nanjapla

After delivering a strong return of 49.4% last year, Chipotle Mexican Grill (CMG) has continued its upward momentum in 2019. The company’s stock has increased by 69.4% YTD as of June 17. Chipotle’s impressive performance in the fourth quarter of 2018 and the first quarter of 2019 has led to a rise in the company’s stock price.

On June 11, ten states filed an antitrust suit to block the proposed Sprint (S) and T-Mobile (TMUS) merger. The lawsuit alleges that the deal could harm competition and raise costs for consumers. It's believed that the US Department of Justice is nearing a final decision.

18 Jun

HollyFrontier Stock Has Slumped 18% This Quarter

WRITTEN BY Maitali Ramkumar

This quarter (started April 1), HollyFrontier (HFC) stock has fallen 18%, while the SPDR S&P 500 ETF (SPY) has risen 2%. Let's look at what's driven HFC stock.

18 Jun

Apple Is Aspiring for the Oscars

WRITTEN BY Sanmit Amin

Apple (AAPL) is getting ready to launch a streaming service later this year. While the tech giant will likely have to spend billions of dollars in the next few years to have a library similar to Netflix's (NFLX), the company has the financial muscle to do so without raising debt.

The utilities sector continues to offer a premium dividend yield along with stable upward price movement. On average, utility stocks are currently yielding 3.2%, while broader markets offer a yield close to ~2%.