The coronavirus pandemic has impacted lots of industries but it didn't slow down the pace of new drug approvals. The FDA greenlighted 59 new drugs last year, and 2021 is shaping up to be a big year too.
If you haven't had time to sift through all of them yourself, don't worry. We've already done the leg work to find the most important ones to watch this year. Read on to see why new drugs from GlaxoSmithKline (GSK -1.89%), Gilead Sciences (GILD -0.17%), and Eli Lilly (LLY -0.97%) made the list.
1. Cabenuva from GlaxoSmithKline
It took longer than expected but the FDA recently made Cabenuva from ViiV Healthcare the first monthly injection approved for the treatment of HIV. This is a long-acting injectable version of two currently available tablets, Edurant from Johnson & Johnson (JNJ -0.15%) and Vocabria from ViiV Healthcare, which is a joint venture between Pfizer (PFE -0.03%), Shionogi, and GlaxoSmithKline.
GlaxoSmithKline controls a majority of ViiV Healthcare and a successful Cabenuva launch is an important component of GlaxoSmithKline's growth strategy. Antiviral treatments can neutralize HIV, but the virus will eventually return in strength without constant vigilance. That makes treating this virus a lucrative endeavor with fierce competition.
GlaxoSmithKline's leading competitor in the HIV space, Gilead Sciences expects sales of Biktarvy, a once-daily HIV tablet that launched in 2018, to reach $10 billion this year. GlaxoSmithKline investors and Gilead Sciences investors will want to keep both eyes on Cabenuva's launch to see if it can knock Biktarvy out of the top spot.
2. Trodelvy from Gilead Sciences
Gilead Sciences has a long-term HIV treatment in clinical trials right now but the company is eager to become a leader in the oncology space. To this end, the company spent $21 billion dollars to acquire Immunomedics and its new breast cancer treatment, Trodelvy.
Gilead Sciences' enormous bet on Trodelvy raised a lot of eyebrows but there's a real chance it could pay off for shareholders. Following the acquisition, we learned that Trodelvy reduced the risk of death by 52% compared to standard care for triple-negative breast cancer patients who had already relapsed after at least two previous lines of treatment.
Trodelvy is a first in class treatment that targets Trop-2, a protein often found on the surface of cancer cells and there's a good chance that it works for a variety of cancer patients that don't respond well to available therapies. If Gilead Sciences really has what it takes to expand beyond antiviral drugs and into the more complicated field of oncology, we'll quickly see Trodelvy become a leading treatment for triple-negative breast cancer and other underserved populations.
3. Retevmo from Eli Lilly
Improving patients' chances of long-term survival is the number one driver of new cancer drug sales, but it also helps if your product can be taken as an easy-to-swallow pill. Retevmo is a small molecule drug that Eli Lilly gained in an $8.0 billion buyout of Loxo Oncology in 2019.
In August, Retevmo earned FDA approval for the treatment of a very limited group of lung cancer patients with tumors driven by rearranged during transfection (RET) mutations. Since then the FDA has expanded its addressable patient population to include people with thyroid cancer driven by the same mutations.
Retevmo's accelerated approvals are based on impressive response rates but a successful launch depends on overall survival data that Eli Lilly hasn't provided yet. In 2020, the FDA approved a new drug similar to Retevmo called Gavreto from collaboration partners Roche (RHHBY -0.73%) and Blueprint Medicines (BPMC 2.28%), for the treatment of the same lung cancer and thyroid cancer patients. So far it looks like Gavreto has a slight safety advantage, so Eli Lilly investors should keep their eyes peeled for competitive survival results from Retevmo.
The new drugs on this list are important to the companies launching them but that doesn't necessarily mean you should run out and dump your pharmaceutical stocks if sales figures disappoint over the next several quarters. No matter what happens to these drug launches, remember it's going to take more than one big commercial flop to sink any of these highly profitable pharma giants.