5 Things Happening in the Pharmacy World Today

In case you missed it...

In case you missed it:

1. Chantix’s Boxed Warning Could Be Removed

Varenicline (Chantix) is a popular smoking cessation drug that has generated $671 million in sales. In 2009, the FDA added a Boxed Warning to its label concerning serious neuropsychiatric events, including depression, suicidal ideation, suicide attempt, and completed suicide.

The EAGLES study compared the neuropsychiatric safety risk and efficacy of Chantix and bupropion (Zyban) with the nicotine patch in 8000 smokers with and without psychiatric disorders. The results showed neither Chantix nor Zyban raised the risk of those adverse effects.

An independent advisory panel recently voted in favor to remove Chantix’s Boxed Warning. Of the 19 panel members, 10 voted to remove the warning, 4 voted to change its wording, and 5 recommended keeping it. Now it’s up to the FDA to decide whether to keep or remove the warning.

2. FDA Rejects Eliquis Antidote

Warfarin has always been the gold standard for venous thromboembolism treatment and stroke/systemic embolism prophylaxis in patients with nonvalvular atrial fibrillation. In the past few years, novel oral anticoagulants (NOACs) like edoxaban (Savaysa), apixaban (Eliquis), rivaroxaban (Xarelto), and dabigatran (Pradaxa) have emerged as alternative treatment because of their favorable pharmacokinetics, pharmacodynamics, and minimal adverse events.

Vitamin K has been the antidote for warfarin for a long time, but the only available antidote for the NOAC class is idarucizumab (Praxbind) for Pradaxa. The lack of other antidotes within the class is worrisome because uncontrollable bleeding can be fatal.

Interim results of the ongoing Phase 3b/4 ANNEXA-4 study demonstrated AndexXa rapidly reversed anticoagulant effects of factor Xa inhibitors, with 79% of patients achieving excellent or good hemostasis over 12 hours. However, the FDA rejected AndexXa and is requiring manufacturer Portola Pharmaceuticals to provide additional information to support the inclusion of 2 other drugs in the antidote’s label: edoxaban and enoxaparin. Portola plans on resubmitting its application by the end of 2016.

3. Terror Tactics Being Used in Vaccine DTC Ads1

Some pharmaceutical companies have started to employ fear-mongering strategies for advertising their vaccines. For example, Pfizer’s ad for its meningitis B vaccine, Trumenba, first shows a little boy celebrating his birthday party, but the next scene shows the little boy pale and weak in the hospital bed because his mom just thought he had the flu. Meanwhile, an ad for GlaxoSmithKline’s whooping cough vaccine, Boostrix, shows a sick grandmother as a wolf holding a baby.

Although I don’t support this strategy, I’m hoping these ads will finally convince antivaxxers to get themselves and their children vaccinated.

4. Another Biosimilar Approved

Biologics and biosimilars have become increasingly popular over the last few years. They’ve been used to treat a variety of diseases and ailments, like cancer, rheumatoid arthritis (RA), and diabetes.

In 2014, 10 of the top 25 best-selling drugs in the United States were biologics and biosimilars. The market for biologics and biosimilars will continue to grow for many more years and continue to change the pharmacy field.

The FDA recently approved Novartis’ Erelzi, a biosimilar to Amgen’s anti-TNF Enbrel. Both can be used to treat rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. Novartis has been on a roll with biosimilars since last year, when it got approval for Zarxio, a biosimilar to Amgen’s Neupogen. Both of these medications stimulate the bone marrow to increase neutrophil production to treat neutropenia.

Hopefully, the emerging biosimilars market will decrease the price of these specialty medications.

5. Bayer Will Buy Monsanto for $66 Billion2

Bayer announced that it will buy Monsanto for $66 billion yesterday, which is the biggest takeover of 2016. Monsanto is the largest agrochemical and agricultural biotechnology company in the world. If this deal goes through, Bayer will control more than a quarter of the world’s market for seeds and pesticides.

This may be bad news for Bayer’s pharma future, since it won’t have enough funds to invest in both pharmaceuticals and agriculture. However, Bayer still has time to position itself as competitive in both industries. The company’s blockbuster drugs, including Xarelto, won’t lose their patents until the 2020s,

References

  • Pasquaderlli A. Halloween already? Big pharma marketers try terror tactics to scare up sales. adage.com/article/cmo-strategy/big-pharma-marketers-terror-tactics/305784/?utm_source=daily_email&utm_medium=newsletter&utm_campaign=adage&ttl=1474256550. Published Septempber 12, 2016.
  • Roumeliotis G, Burger L. Bayer clinches Monsanto with improved $66 billion bid. reuters.com/article/us-monsanto-m-a-bayer-deal-idUSKCN11K128. Published September 15, 2016.